PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)


Device Classification Name

mesh, surgical, polymeric

510(k) Number K110663
Device Name PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
Applicant
SOFRADIM PRODUCTION
15 crosby drive
bedford, 
MA 
01730

Applicant Contact james mcmahon
Correspondent
SOFRADIM PRODUCTION
15 crosby drive
bedford, 
MA 
01730

Correspodent Contact james mcmahon
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 03/08/2011
Decision Date 08/11/2011
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