The following data is part of a premarket notification filed by Arc Medical Supplies (beijing) Co, Ltd. with the FDA for Silk Nonabsorbable Surgical Sutures, Usp.
| Device ID | K000541 |
| 510k Number | K000541 |
| Device Name: | SILK NONABSORBABLE SURGICAL SUTURES, USP |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 40 HILLTOP DR. Syosset, NY 11791 |
| Contact | Richard Kuo |
| Correspondent | Richard Kuo ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 40 HILLTOP DR. Syosset, NY 11791 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-17 |
| Decision Date | 2000-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814639023163 | K000541 | 000 |
| 20814639023132 | K000541 | 000 |