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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 K123865
Device Name VISUAL-ICE CRYOABLATION SYSTEM
Applicant
GALIL MEDICAL INC.
6518 TAMARIND SKY LN
FULSHEAR,  TX  77441
Applicant Contact AMY MCKINNEY
Correspondent
GALIL MEDICAL INC.
6518 TAMARIND SKY LN
FULSHEAR,  TX  77441
Correspondent Contact AMY MCKINNEY
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/17/2012
Decision Date 02/06/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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