WILSON-COOK COLONIC Z-STENT
FDA 510(k) clearance K990034 · decided 2000-04-17
Clearance details
- K-number
- K990034
- Device name
- WILSON-COOK COLONIC Z-STENT
- Applicant
- Med Institute, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-06
- Decision date
- 2000-04-17
- Days to decision
- 467 days
- Clearance type
- Traditional
- Product code
- MQR
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- West Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.