Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K040018 |
Device Name |
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
JAMES D MCMAHON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
JAMES D MCMAHON |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 01/06/2004 |
Decision Date | 01/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|