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FDA 510(k) Application Details - K960882
Device Classification Name
Syringe, Piston
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510(K) Number
K960882
Device Name
Syringe, Piston
Applicant
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE, KY 40217-1865 US
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DAVID PHELPS
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Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
02/20/1996
Decision Date
07/08/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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