FDA 510(k) Application Details - K180949

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K180949
Device Name	Rongeur, Manual
Applicant	RJR Surgical, Inc. 2530 Superior Avenue Cleveland, OH 44114 US Other 510(k) Applications for this Company
Contact	John Redmond 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	04/11/2018
Decision Date	11/08/2018
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