510(k) K083440
K083440 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "PRIMATRIX DERMAL REPAIR SCAFFOLD". The FDA issued a decision of Substantially Equivalent on December 12, 2008. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Tei Biosciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2008
- Date Received
- November 20, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type