The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intrastent.
Device ID | K991929 |
510k Number | K991929 |
Device Name: | INTRASTENT |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
Contact | Cathy Yohnk |
Correspondent | Cathy Yohnk INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-08 |
Decision Date | 1999-08-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTRASTENT 75783899 2618571 Live/Registered |
COVIDIEN LP 1999-08-25 |