SURGICRAFT SURGICAL MESH SYSTEM


Device Classification Name

mesh, surgical, polymeric

510(k) Number K072370
Device Name SURGICRAFT SURGICAL MESH SYSTEM
Applicant
SURGICRAFT LTD.
111 hill road
douglassville, 
PA 
19518

Applicant Contact donald guthner
Correspondent
SURGICRAFT LTD.
111 hill road
douglassville, 
PA 
19518

Correspodent Contact donald guthner
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 08/23/2007
Decision Date 07/24/2008
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