Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K063091 |
Device Name |
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 |
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 | 10/10/2006 |
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 |
Yes
|
Recalls |
CDRH Recalls
|