510(k) K973688
K973688 is an FDA 510(k) premarket notification submitted by Convatec, Ltd. for the device "DUODERM CONTROL GEL FORMULA BORDER DRESSING". The FDA issued a decision of SN on December 23, 1997. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Convatec, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- December 23, 1997
- Date Received
- September 26, 1997
- 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