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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 K063277
Device Name MAPMATE
Applicant
Ep Medsystems, Inc.
Cooper Run Executive Park
575 Route 73 N., Bldg. D
West Berlin,  NJ  08091 -9293
Applicant Contact LARRY PICCIANO
Correspondent
Ep Medsystems, Inc.
Cooper Run Executive Park
575 Route 73 N., Bldg. D
West Berlin,  NJ  08091 -9293
Correspondent Contact LARRY PICCIANO
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/31/2006
Decision Date 11/30/2006
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
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