510(k) K091034
K091034 is an FDA 510(k) premarket notification submitted by Convatec for the device "AQUACEL AG SURGICAL". The FDA issued a decision of Substantially Equivalent on December 16, 2009. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Convatec has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2009
- Date Received
- April 10, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type