DISETRONIC 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 Disetronic Penfine Injection Pen Needle.

Pre-market Notification Details

Device IDK973339
510k NumberK973339
Device Name:DISETRONIC PENFINE INJECTION PEN NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers,  FL  33912
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-05
Decision Date1997-09-24
Summary:summary

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.