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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 K033963
Device Name EP DEFLECTABLE CATHETERS
Applicant
Ep Medsystems, Inc.
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Applicant Contact JAMES E KUHN, JR.
Correspondent
Ep Medsystems, Inc.
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Correspondent Contact JAMES E KUHN, JR.
Regulation Number870.1220
Classification Product Code
DRF  
Date Received12/22/2003
Decision Date 04/15/2004
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
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