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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 K891101
Device Name NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
Applicant
Smith & Nephew United, Inc.
7172 S. W. 47th
P.O. Box 55-7638
Miami,  FL  33255
Applicant Contact JIM IRVIN
Correspondent
Smith & Nephew United, Inc.
7172 S. W. 47th
P.O. Box 55-7638
Miami,  FL  33255
Correspondent Contact JIM IRVIN
Regulation Number878.4014
Classification Product Code
NAB  
Date Received03/02/1989
Decision Date 04/17/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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