Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K980166 |
Device Name |
LIGHTSOURCE OR ILLUMINATOR |
Applicant |
CUDA PRODUCTS CO. |
6000 POWERS AVE. |
JACKSONVILLE,
FL
32217
|
|
Applicant Contact |
KIM REEK |
Correspondent |
CUDA PRODUCTS CO. |
6000 POWERS AVE. |
JACKSONVILLE,
FL
32217
|
|
Correspondent Contact |
KIM REEK |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/16/1998 |
Decision Date | 04/01/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|