The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Nylamid Suture.
Device ID | K931612 |
510k Number | K931612 |
Device Name: | NYLAMID 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 | 1993-04-01 |
Decision Date | 1993-12-17 |