FDA 510(k) Application Details - K051669

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K051669
Device Name Set, I.V. Fluid Transfer
Applicant MIGADA PLANT
PO BOX 888
KIRYAT SHMONA 10258 IL
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Contact YOSSI SHACHAR
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 06/22/2005
Decision Date 09/01/2005
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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