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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K945223
Device Name OREX ISOLATION GOWN
Applicant
Thantex Specialties, Inc.
251 Exchange Pl.
Herndon,  VA  22070
Applicant Contact TOM BONNER
Correspondent
Thantex Specialties, Inc.
251 Exchange Pl.
Herndon,  VA  22070
Correspondent Contact TOM BONNER
Regulation Number878.4040
Classification Product Code
FYC  
Date Received10/26/1994
Decision Date 04/25/1995
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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