Device Classification Name |
Pump, Air, Non-Manual, For Endoscope
|
510(k) Number |
K100899 |
Device Name |
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 |
Applicant |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
11440 WEST BERNARDO DRIVE |
SUITE 300 |
SAN DIEGO,
CA
92127
|
|
Applicant Contact |
RON WARREN |
Correspondent |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
11440 WEST BERNARDO DRIVE |
SUITE 300 |
SAN DIEGO,
CA
92127
|
|
Correspondent Contact |
RON WARREN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/31/2010 |
Decision Date | 09/13/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|