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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K040690
Device Name SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
Applicant
Cryocath Technologies, Inc.
16771 Chemin Suite Marie
Kirkland,  CA H9H 5H3
Applicant Contact FLOR DEL PILAR ARANA
Correspondent
Cryocath Technologies, Inc.
16771 Chemin Suite Marie
Kirkland,  CA H9H 5H3
Correspondent Contact FLOR DEL PILAR ARANA
Regulation Number878.4400
Classification Product Code
OCL  
Date Received03/16/2004
Decision Date 04/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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