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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Pacemaker Electrode Function
510(k) Number K933069
Device Name MODEL EP-2 CLINICAL STIMULATOR
Applicant
Ep Medical, Inc.
54 Rte. 46 W.
Budd Lake,  NJ  07828
Applicant Contact DAVID JENKINS
Correspondent
Ep Medical, Inc.
54 Rte. 46 W.
Budd Lake,  NJ  07828
Correspondent Contact DAVID JENKINS
Regulation Number870.3720
Classification Product Code
DTA  
Date Received06/22/1993
Decision Date 10/21/1993
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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