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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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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