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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 K102021
Device Name CRYO-TOUCH II
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 Received07/19/2010
Decision Date 09/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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