FDA 510(k) Application Details - K133682

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K133682
Device Name	Arthroscope
Applicant	SCHOLLY FIBEROPTIC GMBH 5 WHITCOMB AVENUE AYER, MA 01432 US Other 510(k) Applications for this Company
Contact	PAMELA PAPINEAU, RAC 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	12/02/2013
Decision Date	06/02/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review