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 Lan

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

HTL-Strefa S.A.

The following data is part of a premarket notification filed by Htl-strefa S.a. with the FDA for 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 Lan.

Pre-market Notification Details

Device IDK220643
510k NumberK220643
Device Name: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 Lan
ClassificationSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Applicant HTL-Strefa S.A. Adamowek 7 Ozorkow,  PL 95-035
ContactJustyna Zemigala
CorrespondentJustyna Zemigala
HTL-Strefa S.A. Adamowek 7 Ozorkow,  PL 95-035
Product CodeFMK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-04
Decision Date2022-07-08

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