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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
510(k) Number K041442
Device Name EP-4 CLINICAL STIMUTATOR
Applicant
Ep Medsystems
Cooper Run Executive Park
575 Rt. 73 N., Bldg. D
West Berlin,  NJ  08091
Applicant Contact JAMES E KUHN JR.
Correspondent
Ep Medsystems
Cooper Run Executive Park
575 Rt. 73 N., Bldg. D
West Berlin,  NJ  08091
Correspondent Contact JAMES E KUHN JR.
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received06/01/2004
Decision Date 09/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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