510(k) K023643
K023643 is an FDA 510(k) premarket notification submitted by Macropore Biosurgery, Inc. for the device "MACROPORE SURGICAL BARRIER FILM". The FDA issued a decision of Substantially Equivalent on February 21, 2003. The device falls under product code MTZ (Wrap, Implant, Orbital), a Class II device regulated under 21 CFR 886.3320. Macropore Biosurgery, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2003
- Date Received
- October 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrap, Implant, Orbital
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type