The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Esophageal Prosthesis (double).
| Device ID | K940396 |
| 510k Number | K940396 |
| Device Name: | WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) |
| Classification | Prosthesis, Esophageal |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1994-10-03 |