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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cable, transducer and electrode, patient, (including connector)
510(k) Number K030005
Device Name VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
Original Applicant
VANGUARD MEDICAL CONCEPTS, INC.
5307 great oak dr.
lakeland,  FL  33815
Original Contact mike sammon
Regulation Number870.2900
Classification Product Code
DSA  
Date Received01/02/2003
Decision Date 03/18/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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