The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montg. Tracheal Cannula.
| Device ID | K802916 |
| 510k Number | K802916 |
| Device Name: | MONTG. TRACHEAL CANNULA |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-19 |
| Decision Date | 1980-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34063107100575 | K802916 | 000 |
| 14063107100021 | K802916 | 000 |
| 34063107100872 | K802916 | 000 |
| 34063107100865 | K802916 | 000 |
| 34063107100858 | K802916 | 000 |
| 34063107100841 | K802916 | 000 |
| 34063107100834 | K802916 | 000 |
| 34063107100827 | K802916 | 000 |
| 34063107100810 | K802916 | 000 |
| 14063107100038 | K802916 | 000 |
| 14063107100045 | K802916 | 000 |
| 14063107100120 | K802916 | 000 |
| 14063107100113 | K802916 | 000 |
| 14063107100106 | K802916 | 000 |
| 14063107100090 | K802916 | 000 |
| 14063107100083 | K802916 | 000 |
| 14063107100076 | K802916 | 000 |
| 14063107100069 | K802916 | 000 |
| 14063107100052 | K802916 | 000 |
| 34063107100797 | K802916 | 000 |
| 14063107100786 | K802916 | 000 |
| 34063107100667 | K802916 | 000 |
| 34063107100650 | K802916 | 000 |
| 34063107100636 | K802916 | 000 |
| 34063107100629 | K802916 | 000 |
| 34063107100612 | K802916 | 000 |
| 34063107100605 | K802916 | 000 |
| 34063107100599 | K802916 | 000 |
| 34063107100582 | K802916 | 000 |
| 34063107100674 | K802916 | 000 |
| 34063107100681 | K802916 | 000 |
| 34063107100773 | K802916 | 000 |
| 34063107100766 | K802916 | 000 |
| 34063107100759 | K802916 | 000 |
| 34063107100742 | K802916 | 000 |
| 34063107100735 | K802916 | 000 |
| 34063107100711 | K802916 | 000 |
| 34063107100704 | K802916 | 000 |
| 34063107100698 | K802916 | 000 |
| 14063107100137 | K802916 | 000 |
| EBES3104030 | K802916 | 000 |
| EBES3308330 | K802916 | 000 |
| EBES3308250 | K802916 | 000 |
| EBES3308010 | K802916 | 000 |
| EBES3306650 | K802916 | 000 |
| EBES3306570 | K802916 | 000 |
| EBES3306490 | K802916 | 000 |
| EBES3306410 | K802916 | 000 |
| EBES3306330 | K802916 | 000 |
| EBES3308410 | K802916 | 000 |
| EBES3308490 | K802916 | 000 |
| EBES3310570 | K802916 | 000 |
| EBES3310490 | K802916 | 000 |
| EBES3310410 | K802916 | 000 |
| EBES3310330 | K802916 | 000 |
| EBES3310250 | K802916 | 000 |
| EBES3310010 | K802916 | 000 |
| EBES3308650 | K802916 | 000 |
| EBES3308570 | K802916 | 000 |
| EBES3306250 | K802916 | 000 |
| EBES3306010 | K802916 | 000 |
| EBES3108060 | K802916 | 000 |
| EBES3108040 | K802916 | 000 |
| EBES3108030 | K802916 | 000 |
| EBES3106060 | K802916 | 000 |
| EBES3106040 | K802916 | 000 |
| EBES3106030 | K802916 | 000 |
| EBES3104060 | K802916 | 000 |
| EBES3104040 | K802916 | 000 |
| EBES3110030 | K802916 | 000 |
| EBES3110040 | K802916 | 000 |
| EBES3304650 | K802916 | 000 |
| EBES3304570 | K802916 | 000 |
| EBES3304490 | K802916 | 000 |
| EBES3304410 | K802916 | 000 |
| EBES3304330 | K802916 | 000 |
| EBES3304250 | K802916 | 000 |
| EBES3304010 | K802916 | 000 |
| EBES3110060 | K802916 | 000 |
| EBES3310650 | K802916 | 000 |