CLICKFINE PEN NEEDLE

Needle, Hypodermic, Single Lumen

P/L Biomedical

The following data is part of a premarket notification filed by P/l Biomedical with the FDA for Clickfine Pen Needle.

Pre-market Notification Details

Device IDK122969
510k NumberK122969
Device Name:CLICKFINE PEN NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant P/L Biomedical 10882 STONIGTON AVE Fort Myers,  FL  33913
ContactLee Leichter
CorrespondentLee Leichter
P/L Biomedical 10882 STONIGTON AVE Fort Myers,  FL  33913
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-26
Decision Date2012-10-25
Summary:summary

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