Device Classification Name |
Pump, Air, Non-Manual, For Endoscope
|
510(k) Number |
K100803 |
Device Name |
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 |
Applicant |
KEYMED, INC. |
11440 W. BERNARDO DRIVE |
SUITE 300 |
SAN DIEGO,
CA
92127
|
|
Applicant Contact |
RONALD WARREN |
Correspondent |
KEYMED, INC. |
11440 W. BERNARDO DRIVE |
SUITE 300 |
SAN DIEGO,
CA
92127
|
|
Correspondent Contact |
RONALD WARREN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/22/2010 |
Decision Date | 04/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|