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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Defibrillator
510(k) Number K190437
Device Name Delta 3300
Applicant
Netech Corporation
110 Toledo St.
Farmingdale,  NY  11735
Applicant Contact Mohan Das
Correspondent
Brij Strategic Consultations, LLC
20271 Goldenrod Lane
Suite 2020
Germantown,  MD  20876
Correspondent Contact Mukesh Kumar
Regulation Number870.5325
Classification Product Code
DRL  
Date Received02/22/2019
Decision Date 08/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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