FDA 510(k) Application Details - K171829

Device Classification Name	More FDA Info for this Device
510(K) Number	K171829
Device Name	EndoNaut
Applicant	Therenva SAS 4 rue Jean Jaures Rennes 35000 FR Other 510(k) Applications for this Company
Contact	Matthis HAMY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2017
Decision Date	09/21/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review