Device Classification Name |
Telescope, Rigid, Endoscopic
|
510(k) Number |
K151191 |
Device Name |
OES ELITE Telescopes, Protective Tube |
Applicant |
OLYMPUS WINTER & IBE GMBH |
KUEHNESTRASSE 61 |
HAMBURG,
DE
22045
|
|
Applicant Contact |
KATHARINA SCHNACKENBURG |
Correspondent |
OLYMPUS CORPORATION OF THE AMERICAS |
3500 CORPORATE PARKWAY |
CENTER VALLEY,
PA
18034
|
|
Correspondent Contact |
DAPHNEY GERMAIN-KOLAWOLE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/04/2015 |
Decision Date | 11/24/2015 |
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
|
|
|