510(k) K092926
K092926 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "ACELL MATRISTEM WOUND SHEET". The FDA issued a decision of Substantially Equivalent on October 28, 2009. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Acell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2009
- Date Received
- September 23, 2009
- 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