Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K023902 |
Device Name |
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE |
Applicant |
USGI MEDICAL, INC. |
2 DELPHINUS |
IRVINE,
CA
92612
|
|
Applicant Contact |
JUDY F GORDON |
Correspondent |
USGI MEDICAL, INC. |
2 DELPHINUS |
IRVINE,
CA
92612
|
|
Correspondent Contact |
JUDY F GORDON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/22/2002 |
Decision Date | 08/20/2003 |
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
|
|
|