The following data is part of a premarket notification filed by Arc Medical Supplies (beijing) Co, Ltd. with the FDA for Polypropylene Nonabsorbable Surgical Sutures, Usp.
| Device ID | K000537 |
| 510k Number | K000537 |
| Device Name: | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-17 |
| Decision Date | 2000-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814639023347 | K000537 | 000 |
| 10814639023746 | K000537 | 000 |
| 10814639024798 | K000537 | 000 |
| 20814639022418 | K000537 | 000 |
| 20814639022425 | K000537 | 000 |
| 20814639022432 | K000537 | 000 |
| 20814639022579 | K000537 | 000 |
| 20814639022586 | K000537 | 000 |
| 20814639022807 | K000537 | 000 |
| 20814639022814 | K000537 | 000 |
| 20814639023224 | K000537 | 000 |
| 20814639023286 | K000537 | 000 |
| 20814639023316 | K000537 | 000 |
| 10814639023739 | K000537 | 000 |