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FDA 510(k) Application Details - K113420
Device Classification Name
More FDA Info for this Device
510(K) Number
K113420
Device Name
RNARETAIN
Applicant
ASURAGEN, INC.
2150 WOODWARD ST.
SUITE 100
AUSTIN, TX 78744-1840 US
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Contact
Luc Van Hove
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OZF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2011
Decision Date
03/16/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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