FDA 510(k) Application Details - K993379

Device Classification Name Filter, Infusion Line

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510(K) Number K993379
Device Name Filter, Infusion Line
Applicant PALL CORP.
2200 NORTHERN BLVD.
EAST HILLS, NY 11548 US
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Contact LEONARD S BERMAN
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Regulation Number 880.5440

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Classification Product Code FPB
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Date Received 10/07/1999
Decision Date 12/16/1999
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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