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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 K925401
Device Name IV FLUID TRANSFER PIN
Applicant
B. Braun OF America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018 -0027
Applicant Contact CHRISTINE HARRIS
Correspondent
B. Braun OF America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018 -0027
Correspondent Contact CHRISTINE HARRIS
Regulation Number880.5440
Classification Product Code
LHI  
Date Received10/26/1992
Decision Date 03/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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