The following data is part of a premarket notification filed by Biomedical Ent., Inc. with the FDA for Bme Bone Drill Bits.
| Device ID | K964073 |
| 510k Number | K964073 |
| Device Name: | BME BONE DRILL BITS |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245 |
| Contact | W. Casey Fox |
| Correspondent | W. Casey Fox BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-11 |
| Decision Date | 1996-11-14 |