DISETRONIC PEN

Syringe, Piston

DISETRONIC MEDICAL SYSTEMS

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

Pre-market Notification Details

Device IDK982966
510k NumberK982966
Device Name:DISETRONIC PEN
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-25
Decision Date1998-10-19
Summary:summary

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