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FDA 510(k) Application Details - K140194
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K140194
Device Name
Syringe, Piston
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH, MA 01752 US
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Contact
BRANDON M BRACKETT
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/27/2014
Decision Date
04/14/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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