Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K080216 |
Device Name |
SUPRAMESH EXTRA |
Applicant |
S. JACKSON, INC. |
9109 COPERHAVER DR |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMAN R ESTRIN |
Correspondent |
S. JACKSON, INC. |
9109 COPERHAVER DR |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMAN R ESTRIN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 01/29/2008 |
Decision Date | 09/15/2008 |
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
|
|
|