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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K913783
Device Name CORDIS PTCA GUIDING CATHETER, MODIFICATION
Original Applicant
DOW CORNING WRIGHT
p.o. box 100
arlington,  TN  38002
Original Contact erin mcgurk-burleson
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/14/1991
Decision Date 10/18/1991
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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