The following data is part of a premarket notification filed by Foosin Medical Supplies Inc. with the FDA for Wg-surgical Sutures With Needle.
Device ID | K080684 |
510k Number | K080684 |
Device Name: | WG-SURGICAL SUTURES WITH NEEDLE |
Classification | Suture, Nonabsorbable, Silk |
Applicant | FOOSIN MEDICAL SUPPLIES INC. SUITE 8D, ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE 999 Zhong Shan, Shanghai, CN 20030 |
Contact | Diana Hong |
Correspondent | Diana Hong FOOSIN MEDICAL SUPPLIES INC. SUITE 8D, ZHONGXIN ZHONGSHAN MANSION, NO. 19 LANE 999 Zhong Shan, Shanghai, CN 20030 |
Product Code | GAP |
Subsequent Product Code | GAR |
Subsequent Product Code | GAT |
Subsequent Product Code | GAW |
CFR Regulation Number | 878.5030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-10 |
Decision Date | 2008-06-09 |
Summary: | summary |