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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 K853138
Device Name MILLAR MIKRO-TIP DOPPLER CATHETER
Applicant
Millar Instruments, Inc.
P.O. Box 18227
Houston,  TX  77223
Applicant Contact ROBERT D MIERS
Correspondent
Millar Instruments, Inc.
P.O. Box 18227
Houston,  TX  77223
Correspondent Contact ROBERT D MIERS
Regulation Number870.2880
Classification Product Code
JOP  
Date Received07/26/1985
Decision Date 10/29/1985
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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