Device Classification Name |
Anoscope And Accessories
|
510(k) Number |
K121604 |
Device Name |
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT |
Applicant |
OBP CORPORATION |
360 MERRIMACK STREET |
BUILDING 9 |
LAWRENCE,
MA
01843
|
|
Applicant Contact |
JASON SWIFT |
Correspondent |
OBP CORPORATION |
360 MERRIMACK STREET |
BUILDING 9 |
LAWRENCE,
MA
01843
|
|
Correspondent Contact |
JASON SWIFT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 07/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|