FDA 510(k) Application Details - K161878

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K161878
Device Name	Arthroscope
Applicant	Baylis Medical Company Inc. 2645 Matheson Blvd. East Mississauga L4W 5S4 CA Other 510(k) Applications for this Company
Contact	Meghal Khakhar 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	07/08/2016
Decision Date	09/26/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review