Medical Device Manufacturer · PL , Ozorkow

Htl-Strefa S.A - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2015
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Htl-Strefa S.A General & Plastic Surgery ✕
2 devices
1-2 of 2
Cleared Jul 01, 2025
droplet® personal lancets
K250016 · QRK
General & Plastic Surgery · 179d
Cleared Jul 08, 2022
DropSafe Acti-Lance Safety Lancets
K220643 · FMK
General & Plastic Surgery · 126d
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All7 General Hospital 5 General & Plastic Surgery 2