The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Safe-t-tube Radiopaque.
| Device ID | K930150 |
| 510k Number | K930150 |
| Device Name: | SAFE-T-TUBE RADIOPAQUE |
| Classification | Tube, Tracheal (w/wo Connector) |
| 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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-04 |
| Decision Date | 1993-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34063107100186 | K930150 | 000 |
| 34063107101398 | K930150 | 000 |
| 34063107101404 | K930150 | 000 |
| 34063107101411 | K930150 | 000 |
| 34063107101534 | K930150 | 000 |
| 34063107101541 | K930150 | 000 |
| 34063107101558 | K930150 | 000 |
| 34063107101565 | K930150 | 000 |
| 34063107101572 | K930150 | 000 |
| 34063107101589 | K930150 | 000 |
| 34063107101596 | K930150 | 000 |
| 34063107101602 | K930150 | 000 |
| 34063107101381 | K930150 | 000 |
| 34063107101374 | K930150 | 000 |
| 34063107101367 | K930150 | 000 |
| 34063107100193 | K930150 | 000 |
| 34063107100209 | K930150 | 000 |
| 34063107100216 | K930150 | 000 |
| 34063107101213 | K930150 | 000 |
| 34063107101220 | K930150 | 000 |
| 34063107101237 | K930150 | 000 |
| 34063107101244 | K930150 | 000 |
| 34063107101251 | K930150 | 000 |
| 34063107101268 | K930150 | 000 |
| 34063107101275 | K930150 | 000 |
| 34063107101350 | K930150 | 000 |
| 34063107101619 | K930150 | 000 |
| EBES32006R0 | K930150 | 000 |
| EBES52014R0 | K930150 | 000 |
| EBES52015R0 | K930150 | 000 |
| EBES52016R0 | K930150 | 000 |
| EBES62010R0 | K930150 | 000 |
| EBES62011R0 | K930150 | 000 |
| EBES62012R0 | K930150 | 000 |
| EBES62013R0 | K930150 | 000 |
| EBES62014R0 | K930150 | 000 |
| EBES62015R0 | K930150 | 000 |
| EBES62016R0 | K930150 | 000 |
| EBES71008R0 | K930150 | 000 |
| EBES52013R0 | K930150 | 000 |
| EBES52012R0 | K930150 | 000 |
| EBES52011R0 | K930150 | 000 |
| EBES32007R0 | K930150 | 000 |
| EBES32008R0 | K930150 | 000 |
| EBES32009R0 | K930150 | 000 |
| EBES42010R0 | K930150 | 000 |
| EBES42011R0 | K930150 | 000 |
| EBES42012R0 | K930150 | 000 |
| EBES42013R0 | K930150 | 000 |
| EBES42014R0 | K930150 | 000 |
| EBES42015R0 | K930150 | 000 |
| EBES42016R0 | K930150 | 000 |
| EBES52010R0 | K930150 | 000 |
| EBES71310R0 | K930150 | 000 |