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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 K052530
Device Name SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
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 Received09/14/2005
Decision Date 11/18/2005
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
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