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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, recording, electrode, reprocessed
510(k) Number K043393
Device Name REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS
Applicant
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Applicant Contact JENN SELVEY
Correspondent
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Correspondent Contact JENN SELVEY
Regulation Number870.1220
Classification Product Code
NLH  
Date Received12/10/2004
Decision Date 03/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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