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 |