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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 Rd.
Arden Hills,  MN  55112
Applicant Contact LYNN DAVIES
Correspondent
Galil Medical , Ltd.
4364 Round Lake Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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