Device Classification Name |
cystoscope and accessories, flexible/rigid
|
510(k) Number |
K993689 |
Device Name |
AED CYSTOSCOPE |
Applicant |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
10801 NATIONAL BLVD., #603 |
LOS ANGELES,
CA
90064
|
|
Applicant Contact |
GAYLE M BUTLER |
Correspondent |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
10801 NATIONAL BLVD., #603 |
LOS ANGELES,
CA
90064
|
|
Correspondent Contact |
GAYLE M BUTLER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/01/1999 |
Decision Date | 12/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|