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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, infusion
510(k) Number K896422
Device Name BURRON AMBULATORY DRUG DELIVERY SYSTEM
Original Applicant
BURRON MEDICAL, INC.
824 twelfth ave.
bethlehem,  PA  18018
Original Contact peggy keiffer
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/08/1989
Decision Date 05/09/1990
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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