FDA 510(k) Application Details - K041222

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K041222
Device Name Set, I.V. Fluid Transfer
Applicant B. BRAUN MEDICAL, INC.
1601 WALLACE DR., SUITE 150
CARROLLTON, TX 75006 US
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Contact LINDA MORGAN
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 05/10/2004
Decision Date 10/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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