OLEEVA FABRIC


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K023136
Device Name OLEEVA FABRIC
Original Applicant
BIO MED SCIENCES, INC.
1111 w. hamilton st.
allentown, 
PA 
18101

Original Contact mark e dillon
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 09/20/2002
Decision Date 10/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No