FDA 510(k) Application Details - K150468

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K150468
Device Name	Rongeur, Manual
Applicant	K2 Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen DE Other 510(k) Applications for this Company
Contact	Harald Jung Other 510(k) Applications for this Contact
Regulation Number	882.4840   More FDA Info for this Regulation Number
Classification Product Code	HAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2015
Decision Date	02/29/2016
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