OASYS SURGICAL LIGHT CONTROLLER


Device Classification Name

light, surgical, accessories

510(k) Number K112133
Device Name OASYS SURGICAL LIGHT CONTROLLER
Applicant
OASYS HEALTHCARE
962 allegro lane
apollo beach, 
FL 
33572

Applicant Contact tanya m o’brien
Correspondent
OASYS HEALTHCARE
962 allegro lane
apollo beach, 
FL 
33572

Correspodent Contact tanya m o’brien
Regulation Number 878.4580
Classification Product Code
FTA  
Date Received 07/26/2011
Decision Date 03/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No