FDA 510(k) Application Details - K221126

Device Classification Name	Lancet, Blood   More FDA Info for this Device
510(K) Number	K221126
Device Name	Lancet, Blood
Applicant	Owen Mumford Ltd Brook Hill Woodstock OX20 1TU GB Other 510(k) Applications for this Company
Contact	Darren Mansell 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	04/18/2022
Decision Date	08/12/2022
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