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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 K120415
Device Name CRYO-TOUCH III
Applicant
MYOSCIENCE INC
525 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Applicant Contact TRACEY HENRY
Correspondent
MYOSCIENCE INC
525 CHESAPEAKE DRIVE
REDWOOD CITY,  CA  94063
Correspondent Contact TRACEY HENRY
Regulation Number882.4250
Classification Product Code
GXH  
Date Received02/10/2012
Decision Date 06/22/2012
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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