FDA 510(k) Application Details - K964283

Device Classification Name Filter, Infusion Line

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510(K) Number K964283
Device Name Filter, Infusion Line
Applicant ARBOR TECHNOLOGIES, INC.
401 WEST MORGAN RD.
ANN ARBOR, MI 48108 US
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Contact DAWN I MOORE
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Regulation Number 880.5440

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Classification Product Code FPB
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Date Received 10/28/1996
Decision Date 01/22/1997
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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