C-QUR LITE MESH V-PATCH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K080688
Device Name C-QUR LITE MESH V-PATCH
Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson, 
NH 
03051

Applicant Contact joseph p de paolo
Correspondent
ATRIUM MEDICAL CORP.
5 wentworth dr.
hudson, 
NH 
03051

Correspodent Contact joseph p de paolo
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 03/11/2008
Decision Date 04/16/2008
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