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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K883651
Device Name MILLAR MIKRO-TIP CATHETER PRESSURE 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 Number870.1200
Classification Product Code
DQO  
Date Received08/26/1988
Decision Date 11/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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