510(k) K182010
K182010 is an FDA 510(k) premarket notification submitted by Cell Constructs I, LLC for the device "ProgenaMatrix". The FDA issued a decision of Substantially Equivalent on Jan 17, 2019. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 17, 2019
- Date Received
- Jul 27, 2018
- 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
- Review Panel
- SU
- Submission Type
- 510(k)