FDA 510(k) Application Details - K191345

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K191345
Device Name	Arthroscope
Applicant	A.M. Surgical, Inc. 285 Middle Country Road, Suite 206 Smithtown, NY 11787 US Other 510(k) Applications for this Company
Contact	Vincent Pascale 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	05/20/2019
Decision Date	07/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review