The following data is part of a premarket notification filed by Sulzer Intratherapeutics, Inc. with the FDA for Intrastent Ld (large Diameter) Stent.
| Device ID | K020528 |
| 510k Number | K020528 |
| Device Name: | INTRASTENT LD (LARGE DIAMETER) STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | SULZER INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 -3495 |
| Contact | Glen D Smythe |
| Correspondent | Glen D Smythe SULZER INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 -3495 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684014219 | K020528 | 000 |
| 00821684014066 | K020528 | 000 |
| 00821684014073 | K020528 | 000 |
| 00821684014080 | K020528 | 000 |
| 00821684014097 | K020528 | 000 |
| 00821684014103 | K020528 | 000 |
| 00821684014165 | K020528 | 000 |
| 00821684014172 | K020528 | 000 |
| 00821684014189 | K020528 | 000 |
| 00821684014196 | K020528 | 000 |
| 00821684014202 | K020528 | 000 |
| 00821684014059 | K020528 | 000 |