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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pediatric/Child Facemask
510(k) Number K202831
Device Name The iMask Child's Face Mask
Applicant
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Applicant Contact Jiahe Li
Correspondent
Pac-Dent, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Correspondent Contact Dong He
Regulation Number878.4040
Classification Product Code
OXZ  
Date Received09/25/2020
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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