510(k) K213092
K213092 is an FDA 510(k) premarket notification submitted by Human Biosciences, Inc. for the device "Cellusheet, Cellufil". The FDA issued a decision of Substantially Equivalent on Dec 15, 2021. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Human Biosciences, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2021
- Date Received
- Sep 24, 2021
- 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
- Review Panel
- SU
- Submission Type
- 510(k)