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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 EAST SUNSET RD. SUITE #1
las vegas,  NV  89120
Applicant Contact jeff s schleuing
Correspondent
BIODERMIS CORP.
3078 EAST 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
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