The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montg. Laryngeal Keel.
| Device ID | K842800 |
| 510k Number | K842800 |
| Device Name: | MONTG. LARYNGEAL KEEL |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Contact | Unknown Unknown |
| Correspondent | Unknown Unknown BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-17 |
| Decision Date | 1984-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES3230600 | K842800 | 000 |
| EBES3230500 | K842800 | 000 |
| EBES3230400 | K842800 | 000 |
| 34063107100537 | K842800 | 000 |
| 34063107100513 | K842800 | 000 |
| 34063107100490 | K842800 | 000 |