Device Classification Name |
Prosthesis, Tracheal, Expandable
|
510(k) Number |
K021901 |
Device Name |
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
SHERRY L SPARROW |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
SHERRY L SPARROW |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 06/10/2002 |
Decision Date | 07/09/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|