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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K863930
Device Name VISCOPASTE ZINC PASTE BANDAGE
Applicant
Smith & Nephew, Inc.
1875 Harsh Ave. SE
P.O. Box 550
Massillon,  OH  44648
Applicant Contact GREGORY, JR
Correspondent
Smith & Nephew, Inc.
1875 Harsh Ave. SE
P.O. Box 550
Massillon,  OH  44648
Correspondent Contact GREGORY, JR
Classification Product Code
FRO  
Date Received10/08/1986
Decision Date 12/01/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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