Dermal Cooling System— 510(k) K213294

Substantially Equivalent

R2 Technologies, Inc.

FDA 510(k) clearance K213294 for Dermal Cooling System, Substantially Equivalent on 2022-11-10. Applicant: R2 Technologies, Inc..

Clearance details

Applicant: R2 Technologies, Inc.
Product code: Code QPZ
Advisory panel: General, Plastic Surgery
Date received: 2021-10-01
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

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