Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K983753 |
Device Name |
STAR TEMPORARY WOUND COVER |
Applicant |
OSTEOGENICS, INC. |
7781 LAKEVIEW DR. |
BURLINGTON,
WI
53105 -8119
|
|
Applicant Contact |
MICHAEL DEUTSCH |
Correspondent |
OSTEOGENICS, INC. |
7781 LAKEVIEW DR. |
BURLINGTON,
WI
53105 -8119
|
|
Correspondent Contact |
MICHAEL DEUTSCH |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/16/1998 |
Decision Date | 11/18/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|