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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4780
Classification Product Code
JCX  
Date Received03/26/2008
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
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