The following data is part of a premarket notification filed by Internacional Farmaceutica, S.a. De C.v. with the FDA for Atramat Pgla90 Poly(glycolide-co-l-lactide) Surgical Sutures.
| Device ID | K072859 |
| 510k Number | K072859 |
| Device Name: | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | INTERNACIONAL FARMACEUTICA, S.A. DE C.V. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz INTERNACIONAL FARMACEUTICA, S.A. DE C.V. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-05 |
| Decision Date | 2008-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07500142157349 | K072859 | 000 |
| 07500142129636 | K072859 | 000 |
| 07500142129629 | K072859 | 000 |
| 07500142128240 | K072859 | 000 |
| 07500142125287 | K072859 | 000 |
| 07500142121050 | K072859 | 000 |
| 07500142120664 | K072859 | 000 |
| 07500142120640 | K072859 | 000 |
| 07500142120619 | K072859 | 000 |
| 07500142120596 | K072859 | 000 |
| 07500142120589 | K072859 | 000 |
| 07500142112003 | K072859 | 000 |
| 07500142111990 | K072859 | 000 |
| 07500142133077 | K072859 | 000 |
| 07500142104169 | K072859 | 000 |
| 07500142129643 | K072859 | 000 |
| 07500142129650 | K072859 | 000 |
| 07500142129698 | K072859 | 000 |
| 07500142157332 | K072859 | 000 |
| 07500142157325 | K072859 | 000 |
| 07500142153341 | K072859 | 000 |
| 07500142153327 | K072859 | 000 |
| 07500142134739 | K072859 | 000 |
| 07500142133510 | K072859 | 000 |
| 07500142133497 | K072859 | 000 |
| 07500142132926 | K072859 | 000 |
| 07500142132452 | K072859 | 000 |
| 07500142132377 | K072859 | 000 |
| 07500142132360 | K072859 | 000 |
| 07500142132346 | K072859 | 000 |
| 07500142129728 | K072859 | 000 |
| 07500142129711 | K072859 | 000 |
| 07500142103865 | K072859 | 000 |