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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
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
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
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