The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intrastent Doublestrut Ld.
| Device ID | K993904 |
| 510k Number | K993904 |
| Device Name: | INTRASTENT DOUBLESTRUT LD |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-17 |
| Decision Date | 2000-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684014158 | K993904 | 000 |
| 00821684014011 | K993904 | 000 |
| 00821684014028 | K993904 | 000 |
| 00821684014035 | K993904 | 000 |
| 00821684014042 | K993904 | 000 |
| 00821684014110 | K993904 | 000 |
| 00821684014127 | K993904 | 000 |
| 00821684014134 | K993904 | 000 |
| 00821684014141 | K993904 | 000 |
| 00821684014004 | K993904 | 000 |