DropSafe Safety Pen Needles

Needle, Hypodermic, Single Lumen

HTL STREFA SA

The following data is part of a premarket notification filed by Htl Strefa Sa with the FDA for Dropsafe Safety Pen Needles.

Pre-market Notification Details

Device IDK211716
510k NumberK211716
Device Name:DropSafe Safety Pen Needles
ClassificationNeedle, Hypodermic, Single Lumen
Applicant HTL STREFA SA ul. Adamówek 7 Ozorków,  PL 95-035
ContactJustyna Zemigala
CorrespondentJustyna Zemigala
HTL STREFA SA ul. Adamówek 7 Ozorków,  PL 95-035
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-03
Decision Date2022-01-07

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