The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Iti Stent.
Device ID | K980290 |
510k Number | K980290 |
Device Name: | ITI STENT |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
Contact | Amy Peterson |
Correspondent | Amy Peterson INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-26 |
Decision Date | 1998-07-21 |
Summary: | summary |