COOL-ZONE— 510(k) K963809
Substantially EquivalentKappler USA
FDA 510(k) clearance K963809 for COOL-ZONE, Substantially Equivalent on 1996-11-20. Applicant: Kappler USA. Device class: 2.
Clearance details
- Applicant
- Kappler USA
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guntersville, AL, US
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More clearances from Kappler USA
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