Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K032673 |
Device Name |
IMMIX PLASTIFILM |
Applicant |
OSTEOBIOLOGICS, INC. |
UNIVERSITY BUSINESS PARK |
12500 NETWORK, SUITE 112 |
SAN ANTONIO,
TX
78249 -3308
|
|
Applicant Contact |
GABRIELE G NIEDERAUER |
Correspondent |
OSTEOBIOLOGICS, INC. |
UNIVERSITY BUSINESS PARK |
12500 NETWORK, SUITE 112 |
SAN ANTONIO,
TX
78249 -3308
|
|
Correspondent Contact |
GABRIELE G NIEDERAUER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/29/2003 |
Decision Date | 10/02/2003 |
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
|
|
|