The following data is part of a premarket notification filed by Advance Suture, Inc. with the FDA for Advance Suture Nonabsorbable Dacron Suture.
| Device ID | K903175 |
| 510k Number | K903175 |
| Device Name: | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | ADVANCE SUTURE, INC. P.O. BOX 12428 Tucson, AZ 85732 |
| Contact | Daniel Misenhimer |
| Correspondent | Daniel Misenhimer ADVANCE SUTURE, INC. P.O. BOX 12428 Tucson, AZ 85732 |
| Product Code | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-18 |
| Decision Date | 1991-07-26 |