510(k) K122048
K122048 is an FDA 510(k) premarket notification submitted by Rotation Medical, Inc. for the device "COLLAGEN TENDON SHEET-D". The FDA issued a decision of Substantially Equivalent on January 8, 2013. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Rotation Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2013
- Date Received
- July 12, 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