FDA 510(k) Application Details - K972404

Device Classification Name Flask, Tissue Culture

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510(K) Number K972404
Device Name Flask, Tissue Culture
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
FRANKLIN LAKES, NJ 07417-1880 US
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Contact JOHN SCHALAGO
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Regulation Number 864.2240

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Classification Product Code KJA
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Date Received 06/26/1997
Decision Date 07/22/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee PA - Pathology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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