The following data is part of a premarket notification filed by Synovis Life Technologies, Inc. (baxter International Inc.) with the FDA for Peri-strips Dry With Veritas Collagen Matrix With Secure Grip Technology (psdv-sg).
| Device ID | K192615 |
| 510k Number | K192615 |
| Device Name: | Peri-Strips Dry With Veritas Collagen Matrix With Secure Grip Technology (PSDV-SG) |
| Classification | Mesh, Surgical |
| Applicant | Synovis Life Technologies, Inc. (Baxter International Inc.) 2575 University Ave. W St. Paul, MN 55114 |
| Contact | Megan Sajjad |
| Correspondent | Megan Sajjad Synovis Life Technologies, Inc. (Baxter International Inc.) 2575 University Ave. W St. Paul, MN 55114 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2019-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412658860 | K192615 | 000 |
| 50085412658808 | K192615 | 000 |
| 50085412658853 | K192615 | 000 |
| 50085412658792 | K192615 | 000 |