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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K141485
Device Name ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
Applicant
GALIL MEDICAL LTD.
4364 Round Lake Road
Arden Hills,  MN  55112
Applicant Contact LYNN DAVIES
Correspondent
GALIL MEDICAL LTD.
4364 Round Lake Road
Arden Hills,  MN  55112
Correspondent Contact LYNN DAVIES
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/05/2014
Decision Date 07/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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