Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K072190 |
Device Name |
ORTHO-WRAP BIORESORBABLE SHEET |
Applicant |
MAST BIOSURGERY |
6749 TOP GUN STREET, SUITE 108 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
KENNETH K KLEINHENZ |
Correspondent |
MAST BIOSURGERY |
6749 TOP GUN STREET, SUITE 108 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
KENNETH K KLEINHENZ |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/06/2007 |
Decision Date | 01/16/2008 |
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
|