DISENTRONIC PENFINE INJECTION PEN NEEDLE

Needle, Hypodermic, Single Lumen

DISETRONIC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disentronic Penfine Injection Pen Needle.

Pre-market Notification Details

Device IDK994197
510k NumberK994197
Device Name:DISENTRONIC PENFINE INJECTION PEN NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers,  FL  33912
ContactLee Leichter
CorrespondentLee Leichter
DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers,  FL  33912
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-13
Decision Date1999-12-29
Summary:summary

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