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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K951603
Device Name CARDIMA, INC. FORERUNNER
Applicant
CARDIMA, INC.
47266 BENICIA ST.
P.O. BOX 14172
FREMONT,  CA  94539 -1372
Applicant Contact J. D STEVENS
Correspondent
CARDIMA, INC.
47266 BENICIA ST.
P.O. BOX 14172
FREMONT,  CA  94539 -1372
Correspondent Contact J. D STEVENS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/07/1995
Decision Date 10/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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