The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Osteomill Bone Grinder.
| Device ID | K861164 |
| 510k Number | K861164 |
| Device Name: | OSTEOMILL BONE GRINDER |
| Classification | Bone Mill |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Contact | Kevin J Dunleavy |
| Correspondent | Kevin J Dunleavy BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Product Code | LYS |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-28 |
| Decision Date | 1986-05-02 |