COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
FDA 510(k) clearance K070446 · decided 2007-05-02
Clearance details
- K-number
- K070446
- Device name
- COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
- Applicant
- Valleylab,A Division of Tyco Healthcare Group LP
- Decision
- Substantially Equivalent
- Date received
- 2007-02-15
- Decision date
- 2007-05-02
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.