DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES

Syringe, Piston

EXEL INTL.

The following data is part of a premarket notification filed by Exel Intl. with the FDA for Disposable Syringes And Hypodermic Needles.

Pre-market Notification Details

Device IDK861153
510k NumberK861153
Device Name:DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
ClassificationSyringe, Piston
Applicant EXEL INTL. P.O. BOX 3194 Culver City,  CA  90231 -3194
ContactEshagh Hamid
CorrespondentEshagh Hamid
EXEL INTL. P.O. BOX 3194 Culver City,  CA  90231 -3194
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-26
Decision Date1986-04-23

NIH GUDID Devices

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