Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K121582 |
Device Name |
INVENDO C25 COLONOSCOPY SYSTEM |
Applicant |
INVENDO MEDICAL GBMH |
PETERHOFSTR. 3B |
KISSING,
DE
86438
|
|
Applicant Contact |
OLIVER V RUEPPRECHT |
Correspondent |
INVENDO MEDICAL GBMH |
PETERHOFSTR. 3B |
KISSING,
DE
86438
|
|
Correspondent Contact |
OLIVER V RUEPPRECHT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/30/2012 |
Decision Date | 12/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|