The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Total Knee Kit.
| Device ID | K932918 |
| 510k Number | K932918 |
| Device Name: | TOTAL KNEE KIT |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| 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 | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-15 |
| Decision Date | 1994-09-01 |