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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 K121251
Device Name ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
Applicant
Galil Medical , Ltd.
126 Mesquite St.
Lake Jackson,  TX  77566
Applicant Contact LYNNE DAVIES
Correspondent
Galil Medical , Ltd.
126 Mesquite St.
Lake Jackson,  TX  77566
Correspondent Contact LYNNE DAVIES
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/25/2012
Decision Date 08/28/2012
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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