Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K935031 |
Device Name |
RIZA-RIBE NEEDLE |
Applicant |
R-MED, INC. |
3465 NAVARRE AVE. |
BOX 167636 |
OREGON,
OH
43616 -7636
|
|
Applicant Contact |
EROL D RIZA |
Correspondent |
R-MED, INC. |
3465 NAVARRE AVE. |
BOX 167636 |
OREGON,
OH
43616 -7636
|
|
Correspondent Contact |
EROL D RIZA |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 10/20/1993 |
Decision Date | 04/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|