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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 K211536
Device Name Welspun Health Surgical Mask
Applicant
Welspun India Limited
Survey No. 719, Village: Versamedi, Tal: Anjar
District:Kutch,  IN 370 110
Applicant Contact Satyapriya Dash
Correspondent
Liberty Management Group Limited
75 Executive Drive, Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/18/2021
Decision Date 09/01/2021
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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