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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 K993694
Device Name MIKRO-TIP ANGIOGRAPHIC CATHETER
Original Applicant
MILLAR INSTRUMENTS, INC.
6001 gulf freeway, #534-g
houston,  TX  77023 5417
Original Contact mirielle arce
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/02/1999
Decision Date 03/01/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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