Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K070018 |
Device Name |
UNIVERSAL SURGICAL MESH, MODEL 100 |
Applicant |
GENERIC MEDICAL DEVICE, INC. |
3906 ROSELAND ST. |
HOUSTON,
TX
77006
|
|
Applicant Contact |
MONICA R MONTANEZ |
Correspondent |
GENERIC MEDICAL DEVICE, INC. |
3906 ROSELAND ST. |
HOUSTON,
TX
77006
|
|
Correspondent Contact |
MONICA R MONTANEZ |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 01/03/2007 |
Decision Date | 04/27/2007 |
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
|
|
|