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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K040307
Device Name HANSON SCAR ADE
Applicant
Hanson Medical, Inc.
P.O. Box 1296
Kingston,  WA  98346
Applicant Contact ERIK HANSON
Correspondent
Hanson Medical, Inc.
P.O. Box 1296
Kingston,  WA  98346
Correspondent Contact ERIK HANSON
Regulation Number878.4025
Classification Product Code
MDA  
Date Received02/09/2004
Decision Date 08/12/2004
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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