The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Tracheobronchial Endoprosthesis And Wallstent Tracheobronchial Endoprosthesis With Permalume Covering.
Device ID | K980163 |
510k Number | K980163 |
Device Name: | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING |
Classification | Prosthesis, Tracheal, Expandable |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
Contact | Ronald W Bennett |
Correspondent | Ronald W Bennett BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
Product Code | JCT |
CFR Regulation Number | 878.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-16 |
Decision Date | 1998-03-13 |
Summary: | summary |