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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 K010471
Device Name AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
Applicant
Irvine Biomedical, Inc.
2146-A Michelson Dr.
Irvine,  CA  92612
Applicant Contact JAMES FARNWORTH
Correspondent
Irvine Biomedical, Inc.
2146-A Michelson Dr.
Irvine,  CA  92612
Correspondent Contact JAMES FARNWORTH
Regulation Number870.1220
Classification Product Code
DRF  
Date Received02/20/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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