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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgeon's gloves
510(k) Number K210969
Device Name Nulife
Applicant
MRK Healthcare Pvt Ltd
S.No.153/P&310,Panch, Pippal, Hansapur, Runi, Unjha-Patan
Road
Patan,  IN 384265
Applicant Contact Anil R Dave
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/31/2021
Decision Date 11/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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