HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE

Syringe, Piston

PORTEX, INC.

The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Hypodermic Needle-pro Insulin Syrine & Needle With Needle Protection Device.

Pre-market Notification Details

Device IDK014073
510k NumberK014073
Device Name:HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
ClassificationSyringe, Piston
Applicant PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
ContactBrain E Farias
CorrespondentBrain E Farias
PORTEX, INC. 10 BOWMAN DR. Keene,  NH  03431
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-10
Decision Date2002-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10351688052049 K014073 000
30351688052036 K014073 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.