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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 K082061
Device Name INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
Applicant
Irvine Biomedical, Inc.
2375 Morse Ave.
Irvine,  CA  92614
Applicant Contact JEANETTE HENDRICKSON
Correspondent
Irvine Biomedical, Inc.
2375 Morse Ave.
Irvine,  CA  92614
Correspondent Contact JEANETTE HENDRICKSON
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/21/2008
Decision Date 08/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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