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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 K935166
Device Name FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER
Applicant
Millar Instruments, Inc.
6001-A Gulf Fwy.
Houston,  TX  77023
Applicant Contact JONELL OLIVER
Correspondent
Millar Instruments, Inc.
6001-A Gulf Fwy.
Houston,  TX  77023
Correspondent Contact JONELL OLIVER
Regulation Number870.2870
Classification Product Code
DXO  
Date Received10/27/1993
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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