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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 K060390
Device Name SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
Applicant
GALIL MEDICAL LTD.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHN
Correspondent
GALIL MEDICAL LTD.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHN
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received02/14/2006
Decision Date 04/27/2006
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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