FDA 510(k) Application Details - K250016

Device Classification Name	More FDA Info for this Device
510(K) Number	K250016
Device Name	droplet« personal lancets
Applicant	HTL-Strefa S.A. Adam≤wek 7 Ozork≤w 95-035 PL Other 510(k) Applications for this Company
Contact	Justyna Zemigala Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2025
Decision Date	07/01/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review