ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM


Device Classification Name

apparatus, suction, ward use, portable, ac-powered

510(k) Number K080845
Device Name ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
Applicant
Cardinal Health
1500 waukegan rd. bldg. wm
mcgaw park, 
IL 
60085

Applicant Contact lavenia ford
Regulation Number 878.4780
Classification Product Code
JCX  
Date Received 03/26/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No