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 | K955516 |
| 510k Number | K955516 |
| Device Name: | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE |
| Classification | Tube Tracheostomy And Tube Cuff |
| 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 | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-04 |
| Decision Date | 1995-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES3510021 | K955516 | 000 |
| 34063107100018 | K955516 | 000 |
| 34063107100933 | K955516 | 000 |
| 34063107100988 | K955516 | 000 |
| 34063107101039 | K955516 | 000 |
| 34063107101084 | K955516 | 000 |
| EBES2212011 | K955516 | 000 |
| EBES2212021 | K955516 | 000 |
| EBES3504011 | K955516 | 000 |
| EBES3504021 | K955516 | 000 |
| EBES3506011 | K955516 | 000 |
| EBES3506021 | K955516 | 000 |
| EBES3508011 | K955516 | 000 |
| EBES3508021 | K955516 | 000 |
| EBES3510011 | K955516 | 000 |
| 34063107100001 | K955516 | 000 |