510(k) K090160
K090160 is an FDA 510(k) premarket notification submitted by Polymedics Innovations, GmbH for the device "SUPRATHEL WOUND AND BURN DRESSING". The FDA issued a decision of Substantially Equivalent on May 20, 2009. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device. Polymedics Innovations, GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2009
- Date Received
- January 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Synthetic Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.