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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 K895542
Device Name SONICATH(TM) 5 F
Original Applicant
480 pleasant st.
p.o. box 7407
watertown,  MA  02272
Original Contact alfred couvillon
Regulation Number870.1200
Classification Product Code
Date Received09/13/1989
Decision Date 04/06/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No