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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K070647
Device Name TRIFLEX SELECT
Applicant
Cardinal Health, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact AMY HOYD
Correspondent
Cardinal Health, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact AMY HOYD
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/08/2007
Decision Date 06/22/2007
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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