FDA 510(k) Application Details - K203480

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K203480
Device Name	Arthroscope
Applicant	Hemodia SAS 85 Rue Du Chene Vert Lebege 31670 FR Other 510(k) Applications for this Company
Contact	Adeline Theron 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	11/27/2020
Decision Date	04/05/2021
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	N
Expedited Review