The following data is part of a premarket notification filed by Tepha, Inc. with the FDA for Galastitch Absorbable Monofilament Suture.
| Device ID | K211307 |
| 510k Number | K211307 |
| Device Name: | GalaSTITCH Absorbable Monofilament Suture |
| Classification | Suture, Recombinant Technology |
| Applicant | Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421 |
| Contact | Jodie Giordano |
| Correspondent | Jodie Giordano Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421 |
| Product Code | NWJ |
| CFR Regulation Number | 878.4494 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-29 |
| Decision Date | 2021-05-27 |