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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 K173037
Device Name Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
Applicant
Galil Medical, Inc.
4364 Round Lake Rd.
Arden Hills,  MN  55112
Applicant Contact Lynne Davies
Correspondent
Galil Medical, Inc.
4364 Round Lake Rd.
Arden Hills,  MN  55112
Correspondent Contact Lynne Davies
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/28/2017
Decision Date 11/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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