DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT— 510(k) K011862
Substantially EquivalentDenver Biomedical, Inc.
FDA 510(k) clearance K011862 for DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT, Substantially Equivalent on 2001-07-12. Applicant: Denver Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Denver Biomedical, Inc.
- Product code
- Code KPM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5955
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Golden, CO, US
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