FDA 510(k) Application Details - K223201

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K223201
Device Name	Lancet, Blood
Applicant	YourBio Health, Inc. 200 Boston Avenue Suite 3700 Medford, MA 02155 US Other 510(k) Applications for this Company
Contact	Sean McCarthy Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FMK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2022
Decision Date	04/19/2023
Decision	SESU - SE - WITH LIMITATIONS
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