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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 K130404
Device Name TIBURON SURGICAL DRAPE
Applicant
Cardinal Health200, LLC
1430 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact LAVENIA FORD
Correspondent
Cardinal Health200, LLC
1430 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact LAVENIA FORD
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/19/2013
Decision Date 07/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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