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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 K012497
Device Name CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
Applicant
Galil Medical , Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Galil Medical , Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received08/03/2001
Decision Date 10/30/2001
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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