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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K102923
Device Name BARRIER N95 PARTICULATE RESPIRATOR
Applicant
Molnlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact CAITLIN SENTER
Correspondent
Molnlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact CAITLIN SENTER
Regulation Number878.4040
Classification Product Code
MSH  
Date Received10/01/2010
Decision Date 11/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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