SERISCAFFOLD SURGICAL MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K080442
Device Name SERISCAFFOLD SURGICAL MESH
Applicant
SERICA TECHNOLOGIES, INC.
200 boston avenue
suite 3700
medford, 
MA 
02155

Applicant Contact connie h garrison
Correspondent
SERICA TECHNOLOGIES, INC.
200 boston avenue
suite 3700
medford, 
MA 
02155

Correspodent Contact connie h garrison
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 02/19/2008
Decision Date 11/13/2008
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

Recalls CDRH Recalls