CONTROL SYRINGE

Syringe, Piston

LOUISVILLE LABORATORIES, INC.

The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Control Syringe.

Pre-market Notification Details

Device IDK960882
510k NumberK960882
Device Name:CONTROL SYRINGE
ClassificationSyringe, Piston
Applicant LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville,  KY  40217 -1865
ContactDavid Phelps
CorrespondentDavid Phelps
LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville,  KY  40217 -1865
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-20
Decision Date1996-07-08

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