Paxman Scalp Cooler— 510(k) K163484

Substantially Equivalent

Paxman Coolers Limited

FDA 510(k) clearance K163484 for Paxman Scalp Cooler, Substantially Equivalent on 2017-04-17. Applicant: Paxman Coolers Limited. Device class: 2.

Clearance details

Applicant: Paxman Coolers Limited
Product code: Code PMC
Device class: Class 2
Regulation: 21 CFR 878.4360
Advisory panel: General, Plastic Surgery
Date received: 2016-12-12
Decision date: 2017-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huddersfield, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.