510(k) K780409
K780409 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "COLOPLAST-DURASEAL OSTOMY APPLIANCE". The FDA issued a decision of Substantially Equivalent on April 27, 1978. The device falls under product code EZS (Appliance, Colostomy, Disposable), a Class I device regulated under 21 CFR 876.5900. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 1978
- Date Received
- March 13, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Colostomy, Disposable
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type