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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 K142990
Device Name Insta-Gard Surgical and Procedure Face Mask
Applicant
Cardinal Health200, LLC
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact Lavenia Ford
Correspondent
Cardinal Health200, LLC
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact Lavenia Ford
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/16/2014
Decision Date 03/04/2015
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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