The following data is part of a premarket notification filed by Arc Medical Supplies (beijing) Co, Ltd. with the FDA for Polyester Nonabsorbable Surgical Sutures, Usp.
| Device ID | K000540 |
| 510k Number | K000540 |
| Device Name: | POLYESTER NONABSORBABLE SURGICAL SUTURES, USP |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| 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 |