Device Classification Name |
Endoscopic Irrigation/Suction System
|
510(k) Number |
K103235 |
Device Name |
ERBEFLO 2 DISPOSABLE TUBING SYSTEM |
Applicant |
ERBE USA, INC. |
2225 NORTHWEST PKWY. |
MARIETTA,
GA
30067
|
|
Applicant Contact |
JOHN TARTAL |
Correspondent |
ERBE USA, INC. |
2225 NORTHWEST PKWY. |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
JOHN TARTAL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/02/2010 |
Decision Date | 12/23/2010 |
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
|
|
|