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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K942228
Device Name OREX O.R. TOWEL
Applicant
Thantex Specialties, Inc.
175 Deaverview Rd.
Asheville,  NC  28806
Applicant Contact THOMAS BONNER
Correspondent
Thantex Specialties, Inc.
175 Deaverview Rd.
Asheville,  NC  28806
Correspondent Contact THOMAS BONNER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/06/1994
Decision Date 12/20/1994
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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