XYLOS MACRO-POROUS SURGICAL MESH


Device Classification Name

mesh, surgical

510(k) Number K111584
Device Name XYLOS MACRO-POROUS SURGICAL MESH
Applicant
XYLOS CORPORATION
838 town center dr.
langhorne, 
PA 
19047

Applicant Contact gonzalo c serafica
Correspondent
XYLOS CORPORATION
838 town center dr.
langhorne, 
PA 
19047

Correspodent Contact gonzalo c serafica
Regulation Number 878.3300
Classification Product Code
FTM  
Date Received 06/07/2011
Decision Date 08/25/2011
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