510(k) K081538
K081538 is an FDA 510(k) premarket notification submitted by Rti Biologics, Inc. for the device "TUTOPATCH, TUTOMESH". The FDA issued a decision of Substantially Equivalent on Jun 19, 2008. 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
- Jun 19, 2008
- Date Received
- Jun 2, 2008
- Clearance Type
- Special
- 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)