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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 K181153
Device Name ICEfx Cryoablation System
Applicant
Galil Medical Inc.
4364 Round Lake Road
Arden Hills,  MN  55112
Applicant Contact Rachel Owens
Correspondent
Galil Medical Inc.
4364 Round Lake Road
Arden Hills,  MN  55112
Correspondent Contact Rachel Owens
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/01/2018
Decision Date 05/15/2018
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
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