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FDA 510(k) Applications Submitted by HTL-Strefa S.A.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170988
04/03/2017
DropSafe Safety Pen Needle
HTL-Strefa S.A.
K171982
06/30/2017
DROPLET PEN NEEDLE
HTL-STREFA S.A.
K202340
08/17/2020
Droplet Pen Needle 30G & 33G
HTL-Strefa S.A.
K143437
12/01/2014
Droplet Pen Needles
HTL-STREFA S.A.
K220643
03/04/2022
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets;
HTL-Strefa S.A.
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