BIOMERIX COMPOSITE SURGICAL MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K112499
Device Name BIOMERIX COMPOSITE SURGICAL MESH
Applicant
BIOMERIX CORPORATION
47757 fremont blvd
fremont, 
CA 
94538

Applicant Contact christina l kichula
Correspondent
BIOMERIX CORPORATION
47757 fremont blvd
fremont, 
CA 
94538

Correspodent Contact christina l kichula
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 08/30/2011
Decision Date 12/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No