Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K060329 |
Device Name |
ENDOFAST RELIANT SYSTEM |
Applicant |
ENDOGUN MEDICAL SYSTEMS |
C/O YORAM LEVY |
31 HAAVODA STREET |
BINYAMINA,
IL
30500
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
ENDOGUN MEDICAL SYSTEMS |
C/O YORAM LEVY |
31 HAAVODA STREET |
BINYAMINA,
IL
30500
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/09/2006 |
Decision Date | 09/11/2006 |
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
|