FDA 510(k) Application Details - K181982

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K181982
Device Name	Arthroscope
Applicant	IntraVu, Inc. 610 Price Avenue Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Plamena Entcheva-Dimitrov Other 510(k) Applications for this Contact
Regulation Number	888.1100   More FDA Info for this Regulation Number
Classification Product Code	HRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2018
Decision Date	08/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review