Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K082589 |
Device Name |
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 |
Applicant |
BAROSENSE, INC |
3698-C HAVEN AVENUE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
DANIEL J BALBIERZ |
Correspondent |
BAROSENSE, INC |
3698-C HAVEN AVENUE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
DANIEL J BALBIERZ |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/08/2008 |
Decision Date | 05/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|