The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intrastent Doublestrut Paramount.
Device ID | K001648 |
510k Number | K001648 |
Device Name: | INTRASTENT DOUBLESTRUT PARAMOUNT |
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 | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-30 |
Decision Date | 2000-08-28 |