Device Classification Name |
endoscopic irrigation/suction system
|
510(k) Number |
K190469 |
Device Name |
ERBEFLO 2 Disposable Tubing System |
Applicant |
Erbe USA, Inc. |
2225 Northwest Parkway |
Marietta,
GA
30067
|
|
Applicant Contact |
John Tartal |
Correspondent |
Erbe USA, Inc. |
2225 Northwest Parkway |
Marietta,
GA
30067
|
|
Correspondent Contact |
John Tartal |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/26/2019 |
Decision Date | 05/23/2019 |
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
|
|
|