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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,Nonresorbable For External Use
510(k) Number K921227
Device Name TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
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 Number878.4014
Classification Product Code
NAB  
Date Received03/13/1992
Decision Date 05/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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