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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 K093901
Device Name SURGICAL FACE MASK
Applicant
Epard Protective Products, Ltd.
15637 Fox Cove Circle
Mosely,  VA  23120
Applicant Contact DARREN REEVES
Correspondent
Epard Protective Products, Ltd.
15637 Fox Cove Circle
Mosely,  VA  23120
Correspondent Contact DARREN REEVES
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/22/2009
Decision Date 09/10/2010
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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