COOL.CLICK 2— 510(k) K060819
Substantially EquivalentMedical House Products Limited
FDA 510(k) clearance K060819 for COOL.CLICK 2, Substantially Equivalent on 2006-06-16. Applicant: Medical House Products Limited. Device class: 2.
Clearance details
- Applicant
- Medical House Products Limited
- Product code
- Code KZE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5430
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sheffield, GB
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