510(k) K012025
K012025 is an FDA 510(k) premarket notification submitted by Macropore Biosurgery, Inc. for the device "MACROPORE SURGIWRAP (TS)". The FDA issued a decision of Substantially Equivalent on December 3, 2001. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Macropore Biosurgery, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2001
- Date Received
- June 28, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type