Device Classification Name |
catheter, irrigation
|
510(k) Number |
K131659 |
Device Name |
MOERAE VEIN PREPARATION KIT |
Applicant |
MOERAE MATRIX, INC. |
25 HARTFORD AVENUE |
SAN CARLOS,
CA
94070
|
|
Applicant Contact |
ROBERT J CHIN |
Correspondent |
MOERAE MATRIX, INC. |
25 HARTFORD AVENUE |
SAN CARLOS,
CA
94070
|
|
Correspondent Contact |
ROBERT J CHIN |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 06/06/2013 |
Decision Date | 03/03/2014 |
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
|
|
|