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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