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FDA 510(k) Application Details - K113566
Device Classification Name
Media, Culture, Ex Vivo, Tissue And Cell
More FDA Info for this Device
510(K) Number
K113566
Device Name
Media, Culture, Ex Vivo, Tissue And Cell
Applicant
LIFE TECHNOLOGIES, INC.
3175 STALEY RD.
GRAND ISLAND, NY 14072 US
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Contact
KELLI L TANZELLA
Other 510(k) Applications for this Contact
Regulation Number
876.5885
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Classification Product Code
NDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/2011
Decision Date
06/21/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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