Device Classification Name |
dilator, esophageal
|
510(k) Number |
K933992 |
Device Name |
OLYMPUS SCLEROTHERAPY BALLOON |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
BARRY E SANDS |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
BARRY E SANDS |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 08/17/1993 |
Decision Date | 12/21/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|