The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Wallstent Enteral Endoprosthesis With Unistep Delivery System.
| Device ID | K991056 |
| 510k Number | K991056 |
| Device Name: | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-30 |
| Decision Date | 1999-06-22 |
| Summary: | summary |