Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K120025 |
Device Name |
SURGIMESH XB - SKIRTED |
Applicant |
ASPIDE MEDICAL |
555 THIRTEENTH ST. NW |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JOHN J SMITH |
Correspondent |
ASPIDE MEDICAL |
555 THIRTEENTH ST. NW |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JOHN J SMITH |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/03/2012 |
Decision Date | 06/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|