Dyna Torq Torque Wrench, Torque Wrench
FDA 510(k) K991283 · Micro Motors, Inc.
510(k) numberK991283
Submission
- Device name
- Dyna Torq Torque Wrench, Torque Wrench
- Applicant
- Micro Motors, Inc.
Irvine, CA, US - Received
- April 15, 1999
- Decision date
- August 18, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Dyna Torq Torque Wrench, Torque Wrench cleared by the FDA?
Dyna Torq Torque Wrench, Torque Wrench (K991283) received a 510(k) decision of Substantially Equivalent on August 18, 1999, 125 days after the submission was received.
What is the product code of K991283?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.