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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, surgical
510(k) Number K222426
Device Name Perfetta Moderate Medical Face Mask
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
Applicant Contact Le Pham Minh Ngoc
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/11/2022
Decision Date 09/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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