FDA 510(k) Application Details - K962596

Device Classification Name Tray, Blood Collection

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510(K) Number K962596
Device Name Tray, Blood Collection
Applicant CUSTOMED, INC.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK, NY 11021 US
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Contact CAROLANN KOTULA
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Regulation Number 862.1675

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Classification Product Code GJE
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Date Received 07/02/1996
Decision Date 09/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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