DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T— 510(k) K003451
Substantially EquivalentDenver Biomedicals, Inc.
FDA 510(k) clearance K003451 for DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T, Substantially Equivalent on 2001-01-02. Applicant: Denver Biomedicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Denver Biomedicals, 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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More clearances from Denver Biomedicals, Inc.
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