510(k) K990964
K990964 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "SIGNADRESS DUODERM DRESSING". The FDA issued a decision of Substantially Equivalent on May 18, 1999. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Convatec, A Division of E.R. Squibb & Sons has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1999
- Date Received
- March 23, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type