Device Classification Name |
stent, metallic, expandable, duodenal
|
510(k) Number |
K062750 |
Device Name |
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
ALLYSON BARFORD |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
ALLYSON BARFORD |
Regulation Number | 878.3610
|
Classification Product Code |
|
Date Received | 09/14/2006 |
Decision Date | 12/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|