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FDA 510(k) Application Details - K153553
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K153553
Device Name
Syringe, Piston
Applicant
SiO2 Medical Products
350 Enterprise Drive
Auburn, AL 36830 US
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Contact
Sandra L True
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
12/11/2015
Decision Date
05/17/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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