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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K112323
Device Name CARDIA-CATH
Applicant
Millar Instruments, Inc.
6001-A Gulf Fwy.
Houston,  TX  77023
Applicant Contact FATMA M ALI
Correspondent
Millar Instruments, Inc.
6001-A Gulf Fwy.
Houston,  TX  77023
Correspondent Contact FATMA M ALI
Regulation Number870.2870
Classification Product Code
DXO  
Date Received08/12/2011
Decision Date 10/18/2011
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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