The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery Tracheostomy Speaking Valve.
| Device ID | K955634 |
| 510k Number | K955634 |
| Device Name: | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE |
| Classification | Valve, Non-rebreathing |
| 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 | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES2214011 | K955634 | 000 |