您现在的位置:新闻中心 >> 资讯 >> 公司新闻 >> FDA认证

FDA认证

作者:广源激光来源:广源激光 浏览次数: 日期:2013-06-20
广州广源激光科技有限公司新增FDA认证,成功进入美国市场! This message is to acknowledge receipt of your Initial Product Report , which was filed pursuant to the regulations for the administration and enforcement of the Radiation Control for Health and Safety Act of 1968 (Title 21, Code of Federal Regulations, Subchapter J) as they pertain to the submission information description below. If your submission is a report, it has been filed according to reporting requirements in Title 21, Code of Federal Regulations (CFR), Part 1002. Your submission has been assigned an informal subject title below after “Purpose:”. Your submission has been assigned an ACCESSION NUMBER which can be used by you and FDA to identify your submission. WARNING: THE ACCESSION NUMBER ASSIGNED TO YOUR SUBMISSION DOES NOT IMPLY, CONVEY OR CONSTITUTE FDA APPROVAL OF ANY REPORT, APPLICATION FOR VARIANCE OR EXEMPTION, NOTIFICATION, OR ANY OTHER SUBMISSION OR ITS CONTENTS. THE ACCESSION NUMBER IS ONLY AN ACKNOWLEDGMENT THAT FDA HAS RECEIVED YOUR SUBMISSION. IT MAY BE REVOKED BY FDA. ITS DISCLOSURE IS YOUR RESPONSIBILITY. IT IDENTIFIES YOUR SUBMISSION FOR PRODUCTS OR PRODUCT FAMILIES IDENTIFIED IN THIS MESSAGE. Be advised that failure to comply with FDA regulations may result in notification of affected persons and corrective actions at no cost to the purchaser, pursuant to 21 CFR Part 1003 -- Discovery of Defect or Failure to Comply and 21 CFR Part 1004 --Repurchase, Repairs, or Replacement of Electronic Products. - - - - - - - - - - DOCUMENT RECEIVED, FILED, & ACKNOWLEDGED - - - - - - - - - -This automated notification from the CeSub Submission Process contains general information about the aforementioned submission: Accession Number: 1310335-000 Date Loaded: 5/14/2013 Document Date: 5/14/2013 Establishment Name: HK GREAT YEAR LASER LIMITED This submission is a(n) Purpose: Initial Product Report. These Material Processing Laser Products include designated model(s) GY-1480D, GY-1280H, GY-1610S, GY-1390T, GY-2513TE, GY-9060H, GY-5040M, GY-9060E, GY-1480S, GY-1390E, GY-1410T, GY-1680D, GY-1680S, GY-4030M, GY-1280C, GY-1680H, GY-1280S, GY-6040S, GY-6040M, GY-1480C, GY-1080C, GY-1280D, GY-9060S, GY-1610D, GY-1480H, GY-1080D. Submitter: Lydia Li Email: lydia.li@lcs-cert.com Reporting Official: Deo Liu Email: gy@gdgylaser.com - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - -Please note that your firm is required to submit an Annual Report to CDRH every year by September 1. If you meet all other applicable FDA requirements, you may market the product(s) reported. Please be aware product electronic additional that radiation control or medical device regulations may apply to your product, such as: 21 CFR 1002.11, requiring report certain under supplements circumstances following the same reporting forms as used for product reports on your products 21 CFR 1002.13, requiring annual reports to be submitted each year the using 1 September by appropriate reporting form for annual reports requiring 1050, - 1010 CFR 21 certification to FDA radiation safety performance standards requiring 807, CFR 21 manufacturer registration and device listing, and 21 CFR 807, 812 and 814, requiring medical device clearance or approval For further information see: Radiological Health web site - http://www.fda.gov/Radiation-EmittingProducts/default.htm Gateway Submissions Electronic FDA website -http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm Thank you for your participation in the eSubmitter Program. If any questions or of review during our arise concerns your report, we will notify you. If you have any questions, contact us at (301) 796-5710. Sincerely Yours, Robert J. Doyle Chief, Magnetic Resonance and Electronic Products Branch Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Sent from Huawei Mobile

上一篇:什么是激光?

下一篇:

所属类别: 公司新闻

该资讯的关键词为:新增FDA认证