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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 K003948
Device Name EPI-DERM SILICONE GEL SHEETING
Applicant
Biodermis Corp.
3078 E. Sunset Rd. Suite #1
Las Vegas,  NV  89120
Applicant Contact JEFF S SCHLEUING
Correspondent
Biodermis Corp.
3078 E. Sunset Rd. Suite #1
Las Vegas,  NV  89120
Correspondent Contact JEFF S SCHLEUING
Regulation Number878.4025
Classification Product Code
MDA  
Date Received12/21/2000
Decision Date 01/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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