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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Transducer Signal
510(k) Number K013205
Device Name MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
Applicant
Millar Instruments, Inc.
6001-A Gulf Freeway
Houston,  TX  77023 -5417
Applicant Contact MONICA R MONTANEZ
Correspondent
Millar Instruments, Inc.
6001-A Gulf Freeway
Houston,  TX  77023 -5417
Correspondent Contact MONICA R MONTANEZ
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received09/25/2001
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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