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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; DropSafe Haemolance Plus Safety Lancets

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220643
510(k) Type
Traditional
Applicant
HTL-Strefa S.A.
Country
Poland
FDA Decision
Substantially Equivalent
Decision Date
7/8/2022
Days to Decision
126 days
Submission Type
Summary

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; DropSafe Haemolance Plus Safety Lancets

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220643
510(k) Type
Traditional
Applicant
HTL-Strefa S.A.
Country
Poland
FDA Decision
Substantially Equivalent
Decision Date
7/8/2022
Days to Decision
126 days
Submission Type
Summary