Device Classification Name |
Gastroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K093779 |
Device Name |
CLEARPATH UGI |
Applicant |
EASYGLIDE LTD. |
24301 WOODSAGE DR. |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
EASYGLIDE LTD. |
24301 WOODSAGE DR. |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/09/2009 |
Decision Date | 03/09/2010 |
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
|
|
|