FDA 510(k) Application Details - K191596

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K191596
Device Name	Arthroscope
Applicant	Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Shamsa Karimi 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	06/17/2019
Decision Date	10/09/2019
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