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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K163358
Device Name Introcan Safety 3 Closed IV Catheter
Applicant
B.BRAUN MELSUNGEN AG
1 CARL BRAUN STR.
MELSUNGEN,  DE 34212
Applicant Contact ULRICH JEDELHAUSER
Correspondent
B.BRAUN MEDICAL INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109
Correspondent Contact KIMBERLY SMITH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/30/2016
Decision Date 04/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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