FDA 510(k) Application Details - K163037

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K163037
Device Name	Arthroscope
Applicant	WEMED BIO-TECH INC. RM. D, 7F., NO.96, HOUGANG ST., SHILIN DIST., TAIPEI CITY 111-70, TAIWAN (R.O.C. Taipei City 111 TW Other 510(k) Applications for this Company
Contact	YIN-JIUN TSENG 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	10/31/2016
Decision Date	02/17/2017
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