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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
510(k) Number K182830
Device Name Cardinal HealthTM Poly-Coated Open-Back Protective Gown
Applicant
Cardinal Health200, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Applicant Contact Caroline Miceli
Correspondent
Cardinal Health200, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Correspondent Contact Caroline Miceli
Regulation Number878.4040
Classification Product Code
QPC  
Date Received10/05/2018
Decision Date 04/26/2019
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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