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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 K031117
Device Name SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
Applicant
Galil Medical , Ltd.
Yokneam Gate, 1 Tavor Bldg.
Yokneam,  IL 20692
Applicant Contact RONI ZVULONI
Correspondent
Galil Medical , Ltd.
Yokneam Gate, 1 Tavor Bldg.
Yokneam,  IL 20692
Correspondent Contact RONI ZVULONI
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received04/08/2003
Decision Date 05/23/2003
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
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