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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name probe, test, heart-valve
510(k) Number K881449
Device Name EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116
Original Applicant
BAXTER HEALTHCARE CORP.
p.o. box 11150
santa ana,  CA  92711
Original Contact john l ely
Regulation Number870.4500
Classification Product Code
LXN  
Date Received04/05/1988
Decision Date 06/15/1988
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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