ATRIUM CENTRILFX MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K110110
Device Name ATRIUM CENTRILFX MESH
Applicant
ATRIUM MEDICAL CORPORATION
5 wentworth dr
hudson, 
NH 
03051

Applicant Contact raymond j kelly
Correspondent
ATRIUM MEDICAL CORPORATION
5 wentworth dr
hudson, 
NH 
03051

Correspodent Contact raymond j kelly
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 01/14/2011
Decision Date 02/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No