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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 K974354
Device Name MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
Applicant
Sca Molnlycke
500 Baldwin Tower
Eddystone,  PA  19022
Applicant Contact MIGUEL A NEGRON
Correspondent
Sca Molnlycke
500 Baldwin Tower
Eddystone,  PA  19022
Correspondent Contact MIGUEL A NEGRON
Regulation Number878.4025
Classification Product Code
MDA  
Date Received11/19/1997
Decision Date 03/05/1998
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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