The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Dyna Torq Torque Wrench, Torque Wrench.
| Device ID | K991283 |
| 510k Number | K991283 |
| Device Name: | DYNA TORQ TORQUE WRENCH, TORQUE WRENCH |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MICRO MOTORS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 -1849 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas MICRO MOTORS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 -1849 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-15 |
| Decision Date | 1999-08-18 |