Isolation Gown AAMI Level 3— 510(k) K212504

Substantially Equivalent

Kenpax International Limited

FDA 510(k) clearance K212504 for Isolation Gown AAMI Level 3, Substantially Equivalent on 2021-11-07. Applicant: Kenpax International Limited.

Clearance details

Applicant: Kenpax International Limited
Product code: Code FYC
Advisory panel: General, Plastic Surgery
Date received: 2021-08-09
Decision date: 2021-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

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