COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
FDA 510(k) clearance K945201 · decided 1995-01-04
Clearance details
- K-number
- K945201
- Device name
- COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-25
- Decision date
- 1995-01-04
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.