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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K173803
Device Name Omnican fine
Applicant
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact Kimberly Smith
Correspondent
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact Kimberly Smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/15/2017
Decision Date 06/11/2018
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
Predetermined Change
Control Plan Authorized		 No
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