FDA 510(k) Application Details - K161680

Device Classification Name	Retractor, Self-Retaining, For Neurosurgery   More FDA Info for this Device
510(K) Number	K161680
Device Name	Retractor, Self-Retaining, For Neurosurgery
Applicant	MEDICON EG GANSACKER 15 TUTTLINGEN 78532 DE Other 510(k) Applications for this Company
Contact	Joachim Schmid 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	06/17/2016
Decision Date	03/24/2017
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