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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K021094
Device Name INTROCAN SAFETY IV CATHETER
Original Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown,  PA  18109
Original Contact patricia d wilson
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/04/2002
Decision Date 07/03/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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