EPI-FOAM SILICONE SHEETING


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K991604
Device Name EPI-FOAM SILICONE SHEETING
Applicant
BIODERMIS CORP.
3078 east sunset rd. suite #1
las vegas, 
NV 
89120

Applicant Contact jeff s schleuning
Correspondent
BIODERMIS CORP.
3078 east sunset rd. suite #1
las vegas, 
NV 
89120

Correspodent Contact jeff s schleuning
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 05/10/1999
Decision Date 06/09/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No