The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery Radiopaque Salivary Bypass Tube.
| Device ID | K962688 |
| 510k Number | K962688 |
| Device Name: | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE |
| Classification | Dilator, Esophageal, Ent |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Contact | Stuart K Montgomery |
| Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Product Code | KCF |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-11 |
| Decision Date | 1996-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES322200R0 | K962688 | 000 |
| 34063107100315 | K962688 | 000 |
| 34063107100339 | K962688 | 000 |
| 34063107100353 | K962688 | 000 |
| 34063107100377 | K962688 | 000 |
| 34063107100391 | K962688 | 000 |
| 34063107100414 | K962688 | 000 |
| 34063107100438 | K962688 | 000 |
| EBES322000R0 | K962688 | 000 |
| EBES322080R0 | K962688 | 000 |
| EBES322100R0 | K962688 | 000 |
| EBES322120R0 | K962688 | 000 |
| EBES322140R0 | K962688 | 000 |
| EBES322160R0 | K962688 | 000 |
| EBES322180R0 | K962688 | 000 |
| 34063107100292 | K962688 | 000 |