The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery Safe-t-tube.
| Device ID | K843936 |
| 510k Number | K843936 |
| Device Name: | MONTGOMERY SAFE-T-TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 100 CHARLES RIVER PLAZA 5TH FLOOR Boston, MA 02114 |
| Contact | Stuart K Montgomery |
| Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 100 CHARLES RIVER PLAZA 5TH FLOOR Boston, MA 02114 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-09 |
| Decision Date | 1984-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34063107101473 | K843936 | 000 |
| 34063107101190 | K843936 | 000 |
| 34063107101206 | K843936 | 000 |
| 34063107101282 | K843936 | 000 |
| 34063107101299 | K843936 | 000 |
| 34063107101305 | K843936 | 000 |
| 34063107101312 | K843936 | 000 |
| 34063107101329 | K843936 | 000 |
| 34063107101336 | K843936 | 000 |
| 34063107101343 | K843936 | 000 |
| 34063107101466 | K843936 | 000 |
| 34063107101497 | K843936 | 000 |
| 34063107101503 | K843936 | 000 |
| 34063107101510 | K843936 | 000 |
| 34063107101183 | K843936 | 000 |
| 34063107101176 | K843936 | 000 |
| 34063107101169 | K843936 | 000 |
| 34063107101480 | K843936 | 000 |
| 34063107100148 | K843936 | 000 |
| 34063107100155 | K843936 | 000 |
| 34063107100162 | K843936 | 000 |
| 34063107100179 | K843936 | 000 |
| 34063107100223 | K843936 | 000 |
| 34063107100230 | K843936 | 000 |
| 34063107100247 | K843936 | 000 |
| 34063107100254 | K843936 | 000 |
| 34063107100261 | K843936 | 000 |
| 34063107100278 | K843936 | 000 |
| 34063107101145 | K843936 | 000 |
| 34063107101152 | K843936 | 000 |
| 34063107101527 | K843936 | 000 |
| EBES3200060 | K843936 | 000 |
| EBES5200100 | K843936 | 000 |
| EBES5200110 | K843936 | 000 |
| EBES5200120 | K843936 | 000 |
| EBES5200130 | K843936 | 000 |
| EBES5200140 | K843936 | 000 |
| EBES5200150 | K843936 | 000 |
| EBES5200160 | K843936 | 000 |
| EBES6200100 | K843936 | 000 |
| EBES6200110 | K843936 | 000 |
| EBES6200120 | K843936 | 000 |
| EBES6200130 | K843936 | 000 |
| EBES6200140 | K843936 | 000 |
| EBES6200150 | K843936 | 000 |
| EBES4200160 | K843936 | 000 |
| EBES4200150 | K843936 | 000 |
| EBES4200140 | K843936 | 000 |
| EBES3200070 | K843936 | 000 |
| EBES3200080 | K843936 | 000 |
| EBES3200090 | K843936 | 000 |
| EBES3210660 | K843936 | 000 |
| EBES3210860 | K843936 | 000 |
| EBES3211060 | K843936 | 000 |
| EBES3211070 | K843936 | 000 |
| EBES3211260 | K843936 | 000 |
| EBES3211270 | K843936 | 000 |
| EBES4200100 | K843936 | 000 |
| EBES4200110 | K843936 | 000 |
| EBES4200120 | K843936 | 000 |
| EBES4200130 | K843936 | 000 |
| EBES6200160 | K843936 | 000 |