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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K061762
Device Name TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
Applicant
Cardinal Health, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact LAVENIA FORD
Correspondent
Cardinal Health, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact LAVENIA FORD
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/22/2006
Decision Date 08/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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