Device Classification Name |
Endoscope, Ac-Powered And Accessories
|
510(k) Number |
K860103 |
Device Name |
MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE |
Applicant |
ENDOTHERAPEUTICS |
654 BAIR ISLAND RD. |
SUITE 209 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
RUSSELL THOMPSON |
Correspondent |
ENDOTHERAPEUTICS |
654 BAIR ISLAND RD. |
SUITE 209 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
RUSSELL THOMPSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/10/1986 |
Decision Date | 02/12/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|