The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Universal Bone Cement Kit.
| Device ID | K931540 |
| 510k Number | K931540 |
| Device Name: | UNIVERSAL BONE CEMENT KIT |
| Classification | Cement Obturator |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Contact | Andrew E Taylor |
| Correspondent | Andrew E Taylor BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-29 |
| Decision Date | 1994-01-27 |