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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K070706
Device Name EP-WORKMATE
Applicant
Ep Medsystems
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Applicant Contact LARRY PICCIANO
Correspondent
Ep Medsystems
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Correspondent Contact LARRY PICCIANO
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/14/2007
Decision Date 04/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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