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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 K192374
Device Name Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
Applicant
Cardinal Health 200, LLC
3651 Birchwood Drive
Waukegan,  IL  60085
Applicant Contact Dominic Tunzi
Correspondent
Cardinal Health 200, LLC
3651 Birchwood Drive
Waukegan,  IL  60085
Correspondent Contact Dominic Tunzi
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/30/2019
Decision Date 12/02/2019
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
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