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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 K021010
Device Name MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
Applicant
Endocare, Inc.
7 Studebaker
Irvine,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
Endocare, Inc.
7 Studebaker
Irvine,  CA  92618
Correspondent Contact EBEN GORDON
Regulation Number878.4400
Classification Product Code
OCL  
Date Received03/29/2002
Decision Date 06/06/2002
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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