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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K944953
Device Name OREX MEDICAL BEDDING
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 Number880.6060
Classification Product Code
KME  
Date Received10/07/1994
Decision Date 12/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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