510(k) K904233
K904233 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "CONVATEC ABSORBENT BANDAGE". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code EXE (Protector, Ostomy), a Class I device regulated under 21 CFR 876.5900. 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
- March 6, 1991
- Date Received
- September 5, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Ostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type