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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 K895721
Device Name MILLAR MIKRO-TIP PULSE TRANSDUCER
Applicant
Millar Instruments, Inc.
P.O. Box 18227
Houston,  TX  77223
Applicant Contact ROBERT MCNAMER
Correspondent
Millar Instruments, Inc.
P.O. Box 18227
Houston,  TX  77223
Correspondent Contact ROBERT MCNAMER
Regulation Number870.2870
Classification Product Code
DXO  
Date Received09/25/1989
Decision Date 12/07/1989
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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