The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montg. Tracheal Trephine Fene Strator.
| Device ID | K802915 |
| 510k Number | K802915 |
| Device Name: | MONTG. TRACHEAL TREPHINE FENE STRATOR |
| Classification | Trephine, Sinus |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KBF |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-19 |
| Decision Date | 1980-12-19 |