Device Classification Name |
endoscopic irrigation/suction system
|
510(k) Number |
K193250 |
Device Name |
Irrigation Tubing with CO2 or Air |
Applicant |
KeyMed (Medical and Industrial Equipment) Ltd. |
KeyMed House, Stock Road |
Southend-on-Sea,
GB
SS2 5QH
|
|
Applicant Contact |
Andy Hollingsworth |
Correspondent |
Olympus Surgical Tech America - Gyrus ACMI, Inc. |
136 Turnpike Road |
Southborough,
MA
01772
|
|
Correspondent Contact |
Mary Anne Patella |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/25/2019 |
Decision Date | 04/06/2020 |
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
|
|
|