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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K230569
Device Name Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
Applicant
Cardinalhealth
3651 Birchwood Dr.
Waukegan,  IL  60085
Applicant Contact Caroline Miceli
Correspondent
Cardinalhealth
3651 Birchwood Dr.
Waukegan,  IL  60085
Correspondent Contact Emily Hunter
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/01/2023
Decision Date 07/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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