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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
510(k) Number K885142
Device Name GAUZE SWABS, NON-STERILE
Applicant
Smith & Nephew, Inc.
7174 SW 47 St.
P.O. Box 65-2608
Miami,  FL  33265
Applicant Contact JOHN LUSTIG
Correspondent
Smith & Nephew, Inc.
7174 SW 47 St.
P.O. Box 65-2608
Miami,  FL  33265
Correspondent Contact JOHN LUSTIG
Classification Product Code
EFQ  
Date Received12/15/1988
Decision Date 01/24/1989
Decision Substantially Equivalent (SESE)
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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