Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K100313 |
Device Name |
HYDROFIX SURGICAL SHEET |
Applicant |
MIMEDX GROUP, INC |
811 LIVINGSTON COURT SE |
SUITE B |
MARIETTA,
GA
30067
|
|
Applicant Contact |
SALLY THORSEN |
Correspondent |
MIMEDX GROUP, INC |
811 LIVINGSTON COURT SE |
SUITE B |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
SALLY THORSEN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/04/2010 |
Decision Date | 06/14/2011 |
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
|
|
|