FDA 510(k) Application Details - K221419

Device Classification Name	More FDA Info for this Device
510(K) Number	K221419
Device Name	TD-5010 Lancing Device and TD-5084 Sterile Lancets
Applicant	GOSTAR Co., Ltd. 2F, No.65, Wuquan 7nd Rd. New Taipei City 248020 TW Other 510(k) Applications for this Company
Contact	Pei-Fen Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2022
Decision Date	01/20/2023
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