The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Moore Tracheostomy Tube.
| Device ID | K962240 |
| 510k Number | K962240 |
| Device Name: | MOORE TRACHEOSTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| 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 | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-11 |
| Decision Date | 1996-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBESMTT010LP0 | K962240 | 000 |
| 34063107102401 | K962240 | 000 |
| 34063107102418 | K962240 | 000 |
| 34063107102777 | K962240 | 000 |
| 34063107102784 | K962240 | 000 |
| 34063107102791 | K962240 | 000 |
| 34063107102807 | K962240 | 000 |
| 34063107102814 | K962240 | 000 |
| 34063107102821 | K962240 | 000 |
| EBESMTT0060 | K962240 | 000 |
| EBESMTT006CN0 | K962240 | 000 |
| EBESMTT006LP0 | K962240 | 000 |
| EBESMTT0080 | K962240 | 000 |
| EBESMTT008CN0 | K962240 | 000 |
| EBESMTT008LP0 | K962240 | 000 |
| EBESMTT0100 | K962240 | 000 |
| EBESMTT010CN0 | K962240 | 000 |
| 34063107102395 | K962240 | 000 |