Device Classification Name |
duodenoscope and accessories, flexible/rigid
|
510(k) Number |
K832006 |
Device Name |
PENTAX FD-34A DUODENOFIBERSCOPE |
Applicant |
PENTAX PRECISION INSTRUMENT CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PENTAX PRECISION INSTRUMENT CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/23/1983 |
Decision Date | 08/01/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|