The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Pharyngeal Salivary Bypass Tube.
| Device ID | K923355 |
| 510k Number | K923355 |
| Device Name: | PHARYNGEAL SALIVARY BYPASS TUBE |
| Classification | Dilator, Esophageal, Ent |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
| Contact | Stuart K Montgomery |
| Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
| Product Code | KCF |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-08 |
| Decision Date | 1992-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES355120R0 | K923355 | 000 |
| EBES3551200 | K923355 | 000 |
| 34063107101138 | K923355 | 000 |
| 34063107101121 | K923355 | 000 |