COLOPLAST-DURASEAL OSTOMY APPLIANCE— 510(k) K780409
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K780409 for COLOPLAST-DURASEAL OSTOMY APPLIANCE, Substantially Equivalent on 1978-04-27. Applicant: C.R. Bard, Inc.. Device class: 1.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code EZS
- Device class
- Class 1
- Regulation
- 21 CFR 876.5900
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warrendale, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.