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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K851554
Device Name OVERSHOES (SURCHAUSSURES
Applicant
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Applicant Contact CHAMBORD
Correspondent
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Correspondent Contact CHAMBORD
Regulation Number878.4040
Classification Product Code
FXP  
Date Received04/16/1985
Decision Date 04/30/1985
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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