Device Classification Name |
Endoscopic Irrigation/Suction System
|
510(k) Number |
K122417 |
Device Name |
SCOPEVALET DISPOSABLE BIOPSY VALVE |
Applicant |
THE RUHOF CORP. |
611 WEST 5TH STREET |
THIRD FLOOR |
AUSTIN,
TX
78701
|
|
Applicant Contact |
KIMBERLY MCCOY |
Correspondent |
THE RUHOF CORP. |
611 WEST 5TH STREET |
THIRD FLOOR |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
KIMBERLY MCCOY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/08/2012 |
Decision Date | 05/17/2013 |
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
|