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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, surgical, cryogenic
510(k) Number K173763
Device Name iovera system
Applicant
Myoscience, Inc
46400 Fremont Blvd
Fremont,  CA  94538
Applicant Contact Kent Jones
Correspondent
Myoscience, Inc
46400 Fremont Blvd
Fremont,  CA  94538
Correspondent Contact Kent Jones
Regulation Number882.4250
Classification Product Code
GXH  
Subsequent Product Code
ETN  
Date Received12/11/2017
Decision Date 02/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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