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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K932846
Device Name TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
Applicant
Courtaulds Fibers, Inc.
P.O. Box 141
Axis,  AL  36505
Applicant Contact ROBERT FEIL
Correspondent
Courtaulds Fibers, Inc.
P.O. Box 141
Axis,  AL  36505
Correspondent Contact ROBERT FEIL
Regulation Number878.4450
Classification Product Code
GDY  
Date Received06/10/1993
Decision Date 12/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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