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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 K030303
Device Name FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
Applicant
Cryocath Technologies, Inc.
16771 Chemin Suite Marie
Kirkland,  CA H9H 5H3
Applicant Contact JEAN-PIERRE DESMARAIS
Correspondent
Cryocath Technologies, Inc.
16771 Chemin Suite Marie
Kirkland,  CA H9H 5H3
Correspondent Contact JEAN-PIERRE DESMARAIS
Regulation Number878.4350
Classification Product Code
GEH  
Date Received01/29/2003
Decision Date 04/29/2003
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
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