The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Enteral Endoprothesis.
| Device ID | K954290 |
| 510k Number | K954290 |
| Device Name: | WALLSTENT ENTERAL ENDOPROTHESIS |
| Classification | Stent, Colonic, Metallic, Expandable |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Kathy Jo Fahey |
| Correspondent | Kathy Jo Fahey BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | MQR |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-14 |
| Decision Date | 1996-07-10 |
| Summary: | summary |