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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K940168
Device Name DIAGNOSTIC II CATHETER
Applicant
Ep Technologies, Inc.
350 Potrero Ave.
Sunnyvale,  CA  94086
Applicant Contact ALAN MARQUARDT
Correspondent
Ep Technologies, Inc.
350 Potrero Ave.
Sunnyvale,  CA  94086
Correspondent Contact ALAN MARQUARDT
Regulation Number870.1220
Classification Product Code
DRF  
Date Received01/07/1994
Decision Date 07/27/1994
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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