FDA 510(k) Application Details - K160249

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K160249
Device Name	Arthroscope
Applicant	Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg 22045 DE Other 510(k) Applications for this Company
Contact	Katharina Campbell 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	02/01/2016
Decision Date	04/21/2016
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