FDA 510(k) Application Details - K210741

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K210741
Device Name	Rongeur, Manual
Applicant	KLS-MARTIN L.P. 11201 Saint Johns Industrial Parkway South Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Jennifer Damato 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	03/12/2021
Decision Date	06/03/2022
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