Device Classification Name |
accessories, cleaning, for endoscope
|
510(k) Number |
K093106 |
Device Name |
ENDOSCOPE REPROCESSOR OER-PRO |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/01/2009 |
Decision Date | 02/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|