Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K860192 |
Device Name |
ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE |
Applicant |
ENDOTHERAPEUTICS |
654 BAIR ISLAND RD. |
SUITE 209 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
RUSSELL B THOMPSON |
Correspondent |
ENDOTHERAPEUTICS |
654 BAIR ISLAND RD. |
SUITE 209 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
RUSSELL B THOMPSON |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 01/22/1986 |
Decision Date | 03/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|