PREVADH MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K073287
Device Name PREVADH MESH
Applicant
SOFRADIM PRODUCTION
60 middletown avenue
north haven, 
CT 
06473

Applicant Contact sharon alexander
Correspondent
SOFRADIM PRODUCTION
60 middletown avenue
north haven, 
CT 
06473

Correspodent Contact sharon alexander
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 11/21/2007
Decision Date 03/13/2008
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

Yes