Protective Gown AAMI Level 4— 510(k) K222128

Substantially Equivalent

Kenpax International Limited

FDA 510(k) clearance K222128 for Protective Gown AAMI Level 4, Substantially Equivalent on 2023-08-08. Applicant: Kenpax International Limited.

Clearance details

Applicant: Kenpax International Limited
Product code: Code QPC
Advisory panel: General, Plastic Surgery
Date received: 2022-07-18
Decision date: 2023-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

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