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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 K030026
Device Name REPROCESSED ELECTROPHYSIOLOGY CATHETER
Applicant
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact MOIRA BARTON
Correspondent
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact MOIRA BARTON
Regulation Number870.1220
Classification Product Code
NLH  
Subsequent Product Code
DSA  
Date Received01/03/2003
Decision Date 05/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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