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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 K182870
Device Name Introcan Safety 3 Closed IV Catheter
Applicant
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact Tracy Larish
Correspondent
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact Tracy Larish
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/12/2018
Decision Date 03/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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