FDA 510(k) Application Details - K203526

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K203526
Device Name	Arthroscope
Applicant	CIT Ortho 26202 Detroit Road Ste 340 Westlake, OH 44145 US Other 510(k) Applications for this Company
Contact	Megan Lecavalier 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	12/02/2020
Decision Date	01/12/2021
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	Y
Expedited Review