Device Classification Name |
enteroscope and accessories
|
510(k) Number |
K031256 |
Device Name |
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE |
Applicant |
OLYMPUS OPTO-ELECTRONICS CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
TINA STEFFANIE-OAK |
Correspondent |
OLYMPUS OPTO-ELECTRONICS CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
TINA STEFFANIE-OAK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/21/2003 |
Decision Date | 07/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|