Device Classification Name |
accessories, cleaning, for endoscope
|
510(k) Number |
K103264 |
Device Name |
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034
|
|
Applicant Contact |
STACY ABBATIELL KLUESNER, MS, RAC |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034
|
|
Correspondent Contact |
STACY ABBATIELL KLUESNER, MS, RAC |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/04/2010 |
Decision Date | 02/23/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|