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 |