The following data is part of a premarket notification filed by Antarma Llc Dba Golnit Sutures with the FDA for Golnit Non-aborbable Ptfe Surgical Suture.
| Device ID | K192088 |
| 510k Number | K192088 |
| Device Name: | GOLNIT Non-aborbable PTFE Surgical Suture |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| 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 | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-09-04 |
| Summary: | summary |