Device Classification Name |
mesh, surgical
|
510(k) Number |
K083898 |
Device Name |
SURGIMEND |
Applicant |
TEI BIOSCIENCES INC. |
7 ELKINS ST. |
BOSTON,
MA
02127
|
|
Applicant Contact |
KENNETH JAMES |
Correspondent |
TEI BIOSCIENCES INC. |
7 ELKINS ST. |
BOSTON,
MA
02127
|
|
Correspondent Contact |
KENNETH JAMES |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/29/2008 |
Decision Date | 02/04/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|