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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 K140584
Device Name ICEROD CX CRYOABLATION NEEDLE
Applicant
GALIL MEDICAL LTD.
4364 Round Lake Road
Arden Hills,  MN  55112
Applicant Contact LYNNE DAVIES
Correspondent
GALIL MEDICAL LTD.
4364 Round Lake Road
Arden Hills,  MN  55112
Correspondent Contact LYNNE DAVIES
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/07/2014
Decision Date 03/31/2014
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
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