Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K002650 |
Device Name |
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 |
Applicant |
BENTEC MEDICAL, INC. |
1380 EAST BEAMER ST. |
WOODLAND,
CA
95776
|
|
Applicant Contact |
DAVID TUCKER |
Correspondent |
BENTEC MEDICAL, INC. |
1380 EAST BEAMER ST. |
WOODLAND,
CA
95776
|
|
Correspondent Contact |
DAVID TUCKER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 08/25/2000 |
Decision Date | 02/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|