Perfetta Moderate Medical Face Mask

Mask, Surgical

Phu Bao Group Company Limited

The following data is part of a premarket notification filed by Phu Bao Group Company Limited with the FDA for Perfetta Moderate Medical Face Mask.

Pre-market Notification Details

Device IDK222426
510k NumberK222426
Device Name:Perfetta Moderate Medical Face Mask
ClassificationMask, Surgical
Applicant Phu Bao Group Company Limited 5 Floor, CJ Building, 02Bis-4-6 Le Thanh Ton Street Ben Nghe Ward, District 1 Ho Chi Minh,  VN 70000
ContactLe Pham Minh Ngoc
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-08-11
Decision Date2022-09-02

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