FDA 510(k) Application Details - DEN170064

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170064
Device Name	Comaneci, Comaneci Petit, Comaneci 17
Applicant	Rapid-Medical Ltd. Carmel Building POB 337 Yokneam 2069205 IL Other 510(k) Applications for this Company
Contact	Orit Yaniv Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PUU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2017
Decision Date	04/24/2019
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review