Device Classification Name |
bronchoscope accessory
|
510(k) Number |
K023337 |
Device Name |
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
PAIGE SWEENEY |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
PAIGE SWEENEY |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 10/07/2002 |
Decision Date | 11/18/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|