The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Hemoclip.
Device ID | K211787 |
510k Number | K211787 |
Device Name: | Hemoclip |
Classification | Hemostatic Metal Clip For The Gi Tract |
Applicant | Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
Contact | Yanping Fu |
Correspondent | Yanping Fu Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
Product Code | PKL |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-09 |
Decision Date | 2022-03-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEMOCLIP 73427982 1287014 Live/Registered |
Edward Weck & Company, Inc. 1983-05-27 |
HEMOCLIP 73031424 1014068 Live/Registered |
EDWARD WECK & COMPANY, INC. 1974-09-09 |