FDA 510(k) Application Details - K122861

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K122861
Device Name	Arthroscope
Applicant	OUROBOROS MEDICAL 47757 FREMONT BLVD FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	SHELLEY TRIMM 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	09/18/2012
Decision Date	12/07/2012
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