NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS— 510(k) K061866
Substantially EquivalentThermotek, Inc.
FDA 510(k) clearance K061866 for NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS, Substantially Equivalent on 2006-08-22. Applicant: Thermotek, Inc.. Device class: 2.
Clearance details
- Applicant
- Thermotek, Inc.
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carrollton, TX, US
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