The following data is part of a premarket notification filed by Antarma Dba Golnit Sutures with the FDA for Golnit Non-absorbable Ptfe Surgical Suture.
| Device ID | K163049 |
| 510k Number | K163049 |
| Device Name: | GOLNIT Non-Absorbable PTFE Surgical Suture |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | Antarma Dba Golnit Sutures 1204 Avenue U, #2030 Brooklyn, NY 11229 |
| Contact | Armine Badalyan |
| Correspondent | Armine Badalyan Antarma Dba Golnit Sutures 1204 Avenue U, #2030 Brooklyn, NY 11229 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-06-21 |
| Summary: | summary |