FDA 510(k) Application Details - K112133

Device Classification Name	Light, Surgical, Accessories   More FDA Info for this Device
510(K) Number	K112133
Device Name	Light, Surgical, Accessories
Applicant	OASYS HEALTHCARE 962 ALLEGRO LANE APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	TANYA M O'BRIEN Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2011
Decision Date	03/01/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review