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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 K213136
Device Name CPL Surgical Face Mask
Applicant
Control Print Limited
Village Bhatian, Near Tvs Factory, Bharatgarh Rd., Nalagarh
District Solan,  IN 174101
Applicant Contact Pankaj Sharma
Correspondent
Liberty Management Group , Ltd.
75 Executive Dr., Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/27/2021
Decision Date 12/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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