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FDA 510(k) Application Details - K014114
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K014114
Device Name
Syringe, Piston
Applicant
NIPRO DIABETES SYSTEMS, INC.
1384 COPPERFIELD COURT
LEXINGTON, KY 40514 US
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Contact
KAELYN B HADLEY
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
12/14/2001
Decision Date
06/26/2002
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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