FDA 510(k) Application Details - K040207

Device Classification Name Generator, Pulse, Pacemaker, External Programmable

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510(K) Number K040207
Device Name Generator, Pulse, Pacemaker, External Programmable
Applicant EP MEDSYSTEMS
COOPER RUN EXECUTIVE PARK
575 RT. 73 NORTH, BLDG. D
WEST BERLIN, NJ 08091 US
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Contact JAMES E KUHN
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Regulation Number 870.1750

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Classification Product Code JOQ
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Date Received 01/30/2004
Decision Date 02/27/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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