The following data is part of a premarket notification filed by Synovis Life Technologies. Inc. (a Subsidiary Of Baxter with the FDA for Peri-strips Dry Staple Line Reinforcement With Veritas Collagen Matrix With Secure Grip Technology.
| Device ID | K213125 |
| 510k Number | K213125 |
| Device Name: | PERI-STRIPS Dry Staple Line Reinforcement With VERITAS Collagen Matrix With SECURE GRIP Technology |
| Classification | Mesh, Surgical |
| Applicant | Synovis Life Technologies. Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Ave. W St. Paul, MN 55114 |
| Contact | Megan Sajjad |
| Correspondent | Megan Sajjad Synovis Life Technologies. Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Ave. W St. Paul, MN 55114 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2021-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412658846 | K213125 | 000 |
| 50085412658785 | K213125 | 000 |
| 50085412658839 | K213125 | 000 |
| 50085412658686 | K213125 | 000 |