FDA 510(k) Application Details - K192155

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K192155
Device Name	Arthroscope
Applicant	Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Bryan Cowell 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	08/09/2019
Decision Date	09/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review