Device Classification Name |
prosthesis, tracheal, expandable
|
510(k) Number |
K963241 |
Device Name |
ULTRAFLEX |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
DANIEL J DILLON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
DANIEL J DILLON |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 08/19/1996 |
Decision Date | 11/14/1996 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|