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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Peripheral, Electric
510(k) Number K162048
Device Name EZstim*III Peripheral Nerve Stimulator/Nerve Locator
Applicant
HALYARD HEALTH - IRVINE
43 DISCOVERY, SUITE 100
IRVINE,  CA  92618
Applicant Contact Maria Pronina
Correspondent
HALYARD HEALTH - IRVINE
43 DISCOVERY, SUITE 100
IRVINE,  CA  92618
Correspondent Contact Maria Pronina
Regulation Number868.2775
Classification Product Code
KOI  
Date Received07/25/2016
Decision Date 12/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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