FDA 510(k) Application Details - K153243

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K153243
Device Name	Rongeur, Manual
Applicant	Fehling Instruments GmbH & Co. KG Hanauer Landstr. 7A Karlstein D-63791 DE Other 510(k) Applications for this Company
Contact	Ulrike Lindner 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	11/09/2015
Decision Date	08/04/2016
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