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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
FOIA Releasable 510(k) K021094
Device Name INTROCAN SAFETY IV CATHETER
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109
Applicant Contact PATRICIA D WILSON
Correspondent
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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