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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 Bldg., 02bis-4-6 Le Thanh Ton St.
Ben Nghe Ward, District 1
Ho Chi Minh,  VN 70000
Applicant Contact Le Pham Minh Ngoc
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. 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 General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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