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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 K113860
Device Name VISUAL-ICE CRYOABLATION SYSTEM
Applicant
Galil Medical, Inc.
63 Chicory Ct.
Lake Jackson,  TX  77566
Applicant Contact AMY MCKINNEY
Correspondent
Galil Medical, Inc.
63 Chicory Ct.
Lake Jackson,  TX  77566
Correspondent Contact AMY MCKINNEY
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/30/2011
Decision Date 03/12/2012
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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