Device Classification Name |
Endoscopic Access Overtube, Gastroenterology-Urology
|
510(k) Number |
K033954 |
Device Name |
SHAPE LOCKING ENDOSCOPIC OVERTUBE |
Applicant |
USGI MEDICAL, INC. |
1140 CALLE CORDILLERA |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
JEFFREY A ANDERSON |
Correspondent |
USGI MEDICAL, INC. |
1140 CALLE CORDILLERA |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
JEFFREY A ANDERSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2003 |
Decision Date | 03/19/2004 |
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
|
|
|