The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for N80-838 Supramid Extra Suture.
| Device ID | K912429 |
| 510k Number | K912429 |
| Device Name: | N80-838 SUPRAMID EXTRA SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303 |
| Contact | Jackson |
| Correspondent | Jackson S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-10-02 |