FDA 510(k) Application Details - K954331

Device Classification Name Filter, Infusion Line

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510(K) Number K954331
Device Name Filter, Infusion Line
Applicant PALL BIOMEDICAL PRODUCTS CO.
2200 NORTHERN BLVD.
EAST HILLS, NY 11548 US
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Contact ROBERT A DICKSTEIN
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Regulation Number 880.5440

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Classification Product Code FPB
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Date Received 09/15/1995
Decision Date 01/09/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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