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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 K082023
Device Name REPROCESSED ELECTROPHYSIOLOGY CATHETERS
Applicant
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact AMANDA BABCOCK
Correspondent
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact AMANDA BABCOCK
Regulation Number870.1220
Classification Product Code
NLH  
Date Received07/16/2008
Decision Date 09/16/2008
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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