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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 K133453
Device Name IOVERA
Applicant
MYOSCIENCE INC
1600 SEAPORT BLVD, STE 450
NORTH LOBBY
REDWOOD CITY,  CA  94063
Applicant Contact BIJESH CHANDRAN
Correspondent
MYOSCIENCE INC
1600 SEAPORT BLVD, STE 450
NORTH LOBBY
REDWOOD CITY,  CA  94063
Correspondent Contact BIJESH CHANDRAN
Regulation Number882.4250
Classification Product Code
GXH  
Date Received11/12/2013
Decision Date 03/24/2014
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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