BIOMERIX ASSURE


Device Classification Name

mesh, surgical, polymeric

510(k) Number K112567
Device Name BIOMERIX ASSURE
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 09/02/2011
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