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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K896264
Device Name MILLAR MIKRO-TIP DOPPLER CATHETER
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 Number870.2880
Classification Product Code
JOP  
Date Received10/31/1989
Decision Date 01/24/1990
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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