The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montg. Esophageal -salivary Bypass- Tube.
| Device ID | K812305 |
| 510k Number | K812305 |
| Device Name: | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE |
| Classification | Dilator, Esophageal, Ent |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCF |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-17 |
| Decision Date | 1981-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES3222000 | K812305 | 000 |
| 34063107100308 | K812305 | 000 |
| 34063107100322 | K812305 | 000 |
| 34063107100346 | K812305 | 000 |
| 34063107100360 | K812305 | 000 |
| 34063107100384 | K812305 | 000 |
| 34063107100407 | K812305 | 000 |
| 34063107100421 | K812305 | 000 |
| EBES3220000 | K812305 | 000 |
| EBES3220800 | K812305 | 000 |
| EBES3221000 | K812305 | 000 |
| EBES3221200 | K812305 | 000 |
| EBES3221400 | K812305 | 000 |
| EBES3221600 | K812305 | 000 |
| EBES3221800 | K812305 | 000 |
| 34063107100285 | K812305 | 000 |