FDA 510(k) Application Details - K243306

Device Classification Name	More FDA Info for this Device
510(K) Number	K243306
Device Name	Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-X
Applicant	Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin 300308 CN Other 510(k) Applications for this Company
Contact	Ningning Wang 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	10/21/2024
Decision Date	11/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review