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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 K142866
Device Name Myoscience iovera system
Applicant
Myoscience, Inc.
1600 Seaport Blvd., N. Lobby, Suite 450
Redwood City,  CA  94063
Applicant Contact Tracey Henry
Correspondent
Myoscience, Inc.
1600 Seaport Blvd., N. Lobby, Suite 450
Redwood City,  CA  94063
Correspondent Contact Tracey Henry
Regulation Number882.4250
Classification Product Code
GXH  
Date Received10/01/2014
Decision Date 01/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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