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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 K943034
Device Name OREX SHOE COVERS
Applicant
Thantex Specialties, Inc.
251 Exchange Pl.
Herndon,  VA  22070
Applicant Contact THOMAS B BONNER
Correspondent
Thantex Specialties, Inc.
251 Exchange Pl.
Herndon,  VA  22070
Correspondent Contact THOMAS B BONNER
Regulation Number878.4040
Classification Product Code
FXP  
Date Received06/27/1994
Decision Date 01/02/1995
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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