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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 K192676
Device Name Introcan Safety 2 IV Catheter 18-24 gauge
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 Received09/26/2019
Decision Date 04/01/2020
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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