Device Classification Name |
pneumoperitoneum needle
|
510(k) Number |
K844619 |
Device Name |
ENDONEEDLE |
Applicant |
ENDOTHERAPEUTICS |
654 BAIR ISLAND RD. |
SUITE 209 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
JESSICA WARRING |
Correspondent |
ENDOTHERAPEUTICS |
654 BAIR ISLAND RD. |
SUITE 209 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
JESSICA WARRING |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/27/1984 |
Decision Date | 01/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|