FDA 510(k) Application Details - K180610

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K180610
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	Geister Medizintechnik GmbH Forhenstrasse 2 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Christian Grotzinger 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	03/08/2018
Decision Date	08/29/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review