Device Classification Name |
colonoscope and accessories, flexible/rigid
|
510(k) Number |
K052930 |
Device Name |
NAVIGATOR ENDOSCOPY SYSTEM |
Applicant |
NEOGUIDE SYSTEMS, INC. |
104 COOPER COURT |
LOS GATOS,
CA
95032
|
|
Applicant Contact |
MICHAEL A DANIEL |
Correspondent |
NEOGUIDE SYSTEMS, INC. |
104 COOPER COURT |
LOS GATOS,
CA
95032
|
|
Correspondent Contact |
MICHAEL A DANIEL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/19/2005 |
Decision Date | 01/31/2006 |
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
|
|
|