The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery Laryngeal Stent.
| Device ID | K842287 |
| 510k Number | K842287 |
| Device Name: | MONTGOMERY LARYNGEAL STENT |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-15 |
| Decision Date | 1984-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES3230300 | K842287 | 000 |
| EBES3230250 | K842287 | 000 |
| EBES3230200 | K842287 | 000 |
| EBES3230100 | K842287 | 000 |
| 34063107100483 | K842287 | 000 |
| 34063107100476 | K842287 | 000 |
| 34063107100469 | K842287 | 000 |
| 34063107100445 | K842287 | 000 |