Master-Frank N95 Particulate Respirator— 510(k) K172963

Substantially Equivalent

Master & Frank Enterprise Co., Ltd.

FDA 510(k) clearance K172963 for Master-Frank N95 Particulate Respirator, Substantially Equivalent on 2018-04-04. Applicant: Master & Frank Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant
Master & Frank Enterprise Co., Ltd.
Product code
Code MSH
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dong Duan, CN
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