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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K101623
Device Name INQUIRY AFOCUSII DIAGNOSTIC CATHETER
Applicant
St Jude Medical
2375 Morse Ave.
Irvine,  CA  92614 -6233
Applicant Contact QUYNH PHUONG LE
Correspondent
St Jude Medical
2375 Morse Ave.
Irvine,  CA  92614 -6233
Correspondent Contact QUYNH PHUONG LE
Regulation Number870.1220
Classification Product Code
DRF  
Date Received06/09/2010
Decision Date 08/13/2010
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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