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FDA 510(k) Application Details - K092913
Device Classification Name
Generator, Pulse, Pacemaker, External Programmable
More FDA Info for this Device
510(K) Number
K092913
Device Name
Generator, Pulse, Pacemaker, External Programmable
Applicant
EP MEDSYSTEMS
575 RT. 73 NORTH, BLDG. D
WEST BERLIN, NJ 08091 US
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Contact
SUSHMA RAO
Other 510(k) Applications for this Contact
Regulation Number
870.1750
More FDA Info for this Regulation Number
Classification Product Code
JOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2009
Decision Date
10/16/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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