The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Hebeler Safe-t-tube.
| Device ID | K960450 |
| 510k Number | K960450 |
| Device Name: | HEBELER SAFE-T-TUBE |
| Classification | Tube, Tracheal (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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-30 |
| Decision Date | 1996-04-19 |
| Summary: | summary |