Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K002018 |
Device Name |
NDO SURGICAL SURGICAL OVERTUBE |
Applicant |
SURGICAL, INC. |
125 HIGH STREET, SUITE 7 |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
JEFF CERIER |
Correspondent |
SURGICAL, INC. |
125 HIGH STREET, SUITE 7 |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
JEFF CERIER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/03/2000 |
Decision Date | 08/17/2000 |
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
|
|
|