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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 K201182
Device Name iMask Disposable Surgical Face Mask
Applicant
Pac-Dent, Inc.
670 Endeavor Circle
Brea,  CA  92821
Applicant Contact Jiahe Li
Correspondent
Pac-Dent, Inc.
670 Endeavor Circle
Brea,  CA  92821
Correspondent Contact Jiahe Li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/01/2020
Decision Date 02/19/2021
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
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