FDA 510(k) Application Details - K120384

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K120384
Device Name Set, I.V. Fluid Transfer
Applicant BD MEDICAL-MEDICAL SURGICAL SYSTEMS
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact JOHN ROBERTS
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 02/07/2012
Decision Date 09/12/2012
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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