EPI-DERM SILICONE GEL SHEETING

Elastomer, Silicone, For Scar Management

BIODERMIS CORP.

The following data is part of a premarket notification filed by Biodermis Corp. with the FDA for Epi-derm Silicone Gel Sheeting.

Pre-market Notification Details

Device IDK003948
510k NumberK003948
Device Name:EPI-DERM SILICONE GEL SHEETING
ClassificationElastomer, Silicone, For Scar Management
Applicant BIODERMIS CORP. 3078 EAST SUNSET RD. SUITE #1 Las Vegas,  NV  89120
ContactJeff S Schleuing
CorrespondentJeff S Schleuing
BIODERMIS CORP. 3078 EAST SUNSET RD. SUITE #1 Las Vegas,  NV  89120
Product CodeMDA  
CFR Regulation Number878.4025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-21
Decision Date2001-01-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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