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FDA 510(k) Application Details - K972404
Device Classification Name
Flask, Tissue Culture
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
864.2240
More FDA Info for this Regulation Number
Classification Product Code
KJA
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More FDA Info for this Product Code
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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