DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER— 510(k) K962814
Substantially EquivalentDenver Biomaterials, Inc.
FDA 510(k) clearance K962814 for DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER, Substantially Equivalent on 1997-04-14. Applicant: Denver Biomaterials, Inc.. Device class: 2.
Clearance details
- Applicant
- Denver Biomaterials, 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
- Traditional
- Location
- Evergreen, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.