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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 K990438
Device Name DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
Applicant
Dermaphylyx, Inc.
12106 W. 75th Ln.
Arvada,  CO  80005
Applicant Contact ANDREW M REED
Correspondent
Dermaphylyx, Inc.
12106 W. 75th Ln.
Arvada,  CO  80005
Correspondent Contact ANDREW M REED
Classification Product Code
MGP  
Date Received02/11/1999
Decision Date 03/25/1999
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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