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 Number | 878.4025
|
Classification Product Code |
|
Date Received | 12/21/2000 |
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
|