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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K983794
Device Name CHEMO MINI SPIKE PLUS
Applicant
B. Braun of America, Inc.
901 Marcon Blvd.
Allentown,  PA  18103
Applicant Contact MARK S ALSBERGE
Correspondent
B. Braun of America, Inc.
901 Marcon Blvd.
Allentown,  PA  18103
Correspondent Contact MARK S ALSBERGE
Regulation Number880.5440
Classification Product Code
LHI  
Date Received10/27/1998
Decision Date 03/23/1999
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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