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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 K220670
Device Name Magnum
Applicant
Magnum Health And Safety Pvt Ltd
Unit No. 21, 22, 23, Supreme Industrial Estate, Lucky
Compound, Near Bhajanlal Dairy,Chinchoti Naka,Village Devdal
Taluka - Vasai, Dist - Palghar,  IN 401208
Applicant Contact Rakesh Bhagat
Correspondent
Liberty Management Group Ltd.
75 Executive Drive, Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/07/2022
Decision Date 06/28/2022
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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