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FDA 510(k) Application Details - K143488
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K143488
Device Name
Syringe, Piston
Applicant
PINNACLE SPINE GROUP, LLC
1601 ELM STREET, SUITE 300
DALLAS, TX 75201 US
Other 510(k) Applications for this Company
Contact
Rebecca K Pine
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
12/08/2014
Decision Date
12/17/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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