510(k) K192615
K192615 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. (Baxter International Inc.) for the device "Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)". The FDA issued a decision of Substantially Equivalent on December 17, 2019. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2019
- Date Received
- September 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type