Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K904848 |
Device Name |
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE |
Applicant |
ORIGIN MEDSYSTEMS, INC. |
1900 SOUTH NORFOLK STREET, |
SUITE 312 |
SAN MATEO,
CA
94403
|
|
Applicant Contact |
RICHARD RUSH |
Correspondent |
ORIGIN MEDSYSTEMS, INC. |
1900 SOUTH NORFOLK STREET, |
SUITE 312 |
SAN MATEO,
CA
94403
|
|
Correspondent Contact |
RICHARD RUSH |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 10/26/1990 |
Decision Date | 04/08/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|