FDA 510(k) Application Details - K193630

Device Classification Name	Motor, Drill, Electric   More FDA Info for this Device
510(K) Number	K193630
Device Name	Motor, Drill, Electric
Applicant	Zethon Ltd 2 Halton Brook Business Park Aylesbury hp22 5wf GB Other 510(k) Applications for this Company
Contact	Faith Green Other 510(k) Applications for this Contact
Regulation Number	882.4360   More FDA Info for this Regulation Number
Classification Product Code	HBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2019
Decision Date	04/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review