510(k) K121275
K121275 is an FDA 510(k) premarket notification submitted by Convatec, Inc. for the device "AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER". The FDA issued a decision of Substantially Equivalent on July 25, 2012. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Convatec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2012
- Date Received
- April 27, 2012
- 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