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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 K884354
Device Name IMAGER FLUSH CATHETERS
Original Applicant
MEDI-TECH, INC.
480 plesant st.
p.o. box 7407
watertown,  MA  02272
Original Contact albert p seprinski
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/17/1988
Decision Date 04/21/1989
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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