The following data is part of a premarket notification filed by Antarma Llc Dba Golnit Sutures with the FDA for Golnit Nylon Monofilament Suture.
| Device ID | K212888 |
| 510k Number | K212888 |
| Device Name: | Golnit Nylon Monofilament Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | Antarma LLC Dba Golnit Sutures 276 5th Ave., Suite 704 New York, NY 10001 |
| Contact | Armine Badalyan |
| Correspondent | Armine Badalyan Antarma LLC Dba Golnit Sutures 276 5th Ave., Suite 704 New York, NY 10001 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2022-03-31 |