The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Eliachar Modified Esophageal Stent.
| Device ID | K904821 |
| 510k Number | K904821 |
| Device Name: | ELIACHAR MODIFIED ESOPHAGEAL STENT |
| Classification | Prosthesis, Esophageal |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Lewis H Marten |
| Correspondent | Lewis H Marten HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1991-01-14 |