The following data is part of a premarket notification filed by Arc Medical Supplies (beijing) Co, Ltd. with the FDA for Plain And Chronic Gut Absorbable Surgical Sutures, Usp.
| Device ID | K000542 |
| 510k Number | K000542 |
| Device Name: | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP |
| Classification | Suture, Absorbable, Natural |
| 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 | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| 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 |
|---|---|---|
| 10814639022916 | K000542 | 000 |
| 10814639022909 | K000542 | 000 |
| 10814639022794 | K000542 | 000 |
| 10814639022787 | K000542 | 000 |
| 10814639022770 | K000542 | 000 |
| 10814639022763 | K000542 | 000 |