510(k) K153690
K153690 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 February 22, 2016. 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
- February 22, 2016
- Date Received
- December 23, 2015
- Clearance Type
- Traditional
- 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