COOL-ZONE— 510(k) K963809

Substantially Equivalent

Kappler USA

FDA 510(k) clearance K963809 for COOL-ZONE, Substantially Equivalent on 1996-11-20. Applicant: Kappler USA.

Clearance details

Applicant
Kappler USA
Product code
Code FYA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guntersville, AL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.