510(k) K021160
K021160 is an FDA 510(k) premarket notification submitted by Carbon Medical Technologies, Inc. for the device "DERMMATRIX SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on June 12, 2002. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Carbon Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2002
- Date Received
- April 11, 2002
- 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