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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 K211765
Device Name Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
Applicant
Cardinal Health, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Applicant Contact Brenda Gerena
Correspondent
Cardinal Health, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Correspondent Contact Brenda Gerena
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/08/2021
Decision Date 11/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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