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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name N95 Respirator With Antimicrobial/Antiviral Agent
510(k) Number K081923
Device Name ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
Applicant
Glaxosmithkline Consumer Healthcare
1500 Littleton Rd.
Parsippany,  NJ  07054 -3884
Applicant Contact ZINATARA A MANJI
Correspondent
Glaxosmithkline Consumer Healthcare
1500 Littleton Rd.
Parsippany,  NJ  07054 -3884
Correspondent Contact ZINATARA A MANJI
Regulation Number878.4040
Classification Product Code
ONT  
Date Received07/07/2008
Decision Date 07/01/2009
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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