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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 STREET
LAKE JACKSON,  TX  77566
Applicant Contact LYNNE DAVIES
Correspondent
GALIL MEDICAL LTD.
126 MESQUITE STREET
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
Recalls CDRH Recalls
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