FDA 510(k) Application Details - K200387

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K200387
Device Name	Rongeur, Manual
Applicant	Ace Medical 2230 Park Ave. #202 Cincinnati, OH 45206 US Other 510(k) Applications for this Company
Contact	Alex Ebner 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	02/18/2020
Decision Date	07/21/2020
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