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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K061308
Device Name TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
Applicant
Cardinal Health 200, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60685
Applicant Contact LAVENIA FORD
Correspondent
Cardinal Health 200, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60685
Correspondent Contact LAVENIA FORD
Regulation Number878.4040
Classification Product Code
FYA  
Date Received05/10/2006
Decision Date 06/05/2006
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
Recalls CDRH Recalls
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