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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 K181741
Device Name IceSphere 1.5 CX Cryoablation Needle
Galil Medical Ltd.
Tavor 1 Building, Industrial Park, PO Box 224
Yokneam,  IL 2069203
Applicant Contact Stacey Backlund
Galil Medical Inc.
4364 Round Lake Road
Arden Hills,  MN  55112
Correspondent Contact Stacey Bucklund
Regulation Number878.4350
Classification Product Code
Date Received07/02/2018
Decision Date 07/30/2018
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