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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 K022008
Device Name CARDIMA ABLATION SYSTEM
Applicant
Cardima, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Applicant Contact ROBERT A CHIN
Correspondent
Cardima, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Correspondent Contact ROBERT A CHIN
Regulation Number878.4400
Classification Product Code
OCL  
Date Received06/19/2002
Decision Date 01/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
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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