Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K053656 |
FOIA Releasable 510(k) |
K053656
|
Device Name |
TYRX ANTIMICROBIAL MESH |
Applicant |
TYRX PHARMA INC |
1 DEER PARK DR |
SUITE G |
MONMOUTH JUNCTION,
NJ
08852
|
|
Applicant Contact |
MASON W DIAMOND |
Correspondent |
TYRX PHARMA INC |
1 DEER PARK DR |
SUITE G |
MONMOUTH JUNCTION,
NJ
08852
|
|
Correspondent Contact |
MASON W DIAMOND |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/30/2005 |
Decision Date | 07/14/2006 |
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 |
Yes
|