510(k) K123356
K123356 is an FDA 510(k) premarket notification submitted by Rti Biologics, Inc. for the device "FORTIVA PORCINE DERMIS". The FDA issued a decision of Substantially Equivalent on Mar 5, 2013. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Rti Biologics, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 5, 2013
- Date Received
- Oct 31, 2012
- 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
- 510(k)