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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 K864264
Device Name TRICOTEX WOUND CONTACT LAYER DRESSING
Applicant
Smith & Nephew, Inc.
1875 Harsh Ave. SE
P.O. Box 550
Massillon,  OH  44648
Applicant Contact HOMER GREGORY
Correspondent
Smith & Nephew, Inc.
1875 Harsh Ave. SE
P.O. Box 550
Massillon,  OH  44648
Correspondent Contact HOMER GREGORY
Regulation Number878.4014
Classification Product Code
NAB  
Date Received10/29/1986
Decision Date 12/29/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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