Device Classification Name |
dislodger, stone, biliary
|
510(k) Number |
K071066 |
Device Name |
SPYCATCH STONE RETRIEVAL BASKET |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MAILSTOP M11 |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
NEIL KELLY |
Correspondent |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MAILSTOP M11 |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
NEIL KELLY |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/16/2007 |
Decision Date | 06/29/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|