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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 K951913
Device Name OVAL SURGICAL FACE MASK
Applicant
Oval Industries, Ltd.
P.O. Box 479
Stoughton,  MA  02072
Applicant Contact RICHARD A DOMAINQUE
Correspondent
Oval Industries, Ltd.
P.O. Box 479
Stoughton,  MA  02072
Correspondent Contact RICHARD A DOMAINQUE
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/24/1995
Decision Date 10/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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