Surgical Cutting Burs
FDA 510(k) K943540 · Stryker Corp.
510(k) numberK943540
Submission
- Device name
- Surgical Cutting Burs
- Applicant
- Stryker Corp.
Portage, MI, US - Received
- July 22, 1994
- Decision date
- November 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Surgical Cutting Burs cleared by the FDA?
Surgical Cutting Burs (K943540) received a 510(k) decision of Substantially Equivalent on November 30, 1994, 131 days after the submission was received.
What is the product code of K943540?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.