DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
FDA 510(k) clearance K973129 · decided 1998-03-17
Clearance details
- K-number
- K973129
- Device name
- DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
- Applicant
- Denver Biomaterials, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-21
- Decision date
- 1998-03-17
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- KPM
- Device class
- 2
- Regulation number
- 876.5955
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Evergreen, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.