Device Classification Name |
Endoscopic Access Overtube, Gastroenterology-Urology
|
510(k) Number |
K052084 |
Device Name |
ENDO-EASE ENDOSCOPIC OVERTUBE |
Applicant |
SPIRUS MEDICAL, INC. |
5 WHITCOMB AVENUE |
AYER,
MA
01432
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
SPIRUS MEDICAL, INC. |
5 WHITCOMB AVENUE |
AYER,
MA
01432
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/02/2005 |
Decision Date | 09/14/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|