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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 And Burn, Occlusive
510(k) Number K984371
Device Name MEPITEL NON ADHERENT SILICONE DRESSING
Applicant
Molnlycke Health Care, Inc.
500 Baldwin Tower
Eddystone,  PA  19022
Applicant Contact MIGUEL A NEGRON
Correspondent
Molnlycke Health Care, Inc.
500 Baldwin Tower
Eddystone,  PA  19022
Correspondent Contact MIGUEL A NEGRON
Classification Product Code
MGP  
Date Received12/07/1998
Decision Date 03/03/1999
Decision Substantially Equivalent (SESE)
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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