COBRA COOLED SURGICAL PROBE, MODEL 1596X
FDA 510(k) clearance K021046 · decided 2002-04-16
Clearance details
- K-number
- K021046
- Device name
- COBRA COOLED SURGICAL PROBE, MODEL 1596X
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2002-04-01
- Decision date
- 2002-04-16
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.