BARD 3DMAX MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K081010
Device Name BARD 3DMAX MESH
Applicant
DAVOL INC., SUB. C.R. BARD, INC.
100 sockanossett crossroad
cranston, 
RI 
02920

Applicant Contact stephanie baker
Correspondent
DAVOL INC., SUB. C.R. BARD, INC.
100 sockanossett crossroad
cranston, 
RI 
02920

Correspodent Contact stephanie baker
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 04/09/2008
Decision Date 10/07/2008
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