FDA 510(k) Application Details - K202072

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K202072
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	Minnetronix Neuro, INC. 1635 Energy Park Drive St. Paul, MN 55108 US Other 510(k) Applications for this Company
Contact	Matt Adams Other 510(k) Applications for this Contact
Regulation Number	882.4800   More FDA Info for this Regulation Number
Classification Product Code	GZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2020
Decision Date	08/26/2020
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	Y
Expedited Review