510(k) K053476
K053476 is an FDA 510(k) premarket notification submitted by At Squared, LLC for the device "ALLWOUND". The FDA issued a decision of Substantially Equivalent on June 26, 2006. The device falls under product code SEJ (Wound Dressings Containing Topical Analgesics), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2006
- Date Received
- December 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressings Containing Topical Analgesics
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.