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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 K990891
Device Name DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID 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
FRO  
Date Received03/17/1999
Decision Date 05/27/1999
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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