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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 K991025
Device Name LUMA-CATH FIXED CURVE EP CATHETERS
Applicant
Irvine Biomedical, Inc.
2146-A Michelson Dr.
Irvine,  CA  92612
Applicant Contact ROGER TU
Correspondent
Irvine Biomedical, Inc.
2146-A Michelson Dr.
Irvine,  CA  92612
Correspondent Contact ROGER TU
Regulation Number870.1220
Classification Product Code
DRF  
Date Received03/29/1999
Decision Date 10/15/1999
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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