DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER— 510(k) K011020
Substantially EquivalentDenver Biomedicals, Inc.
FDA 510(k) clearance K011020 for DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER, Substantially Equivalent on 2001-06-01. 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
- Louisville, CO, US
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