Safetywand Disposable Handpiece
FDA 510(k) K023722 · Spintech, Inc.
510(k) numberK023722
Submission
- Device name
- Safetywand Disposable Handpiece
- Applicant
- Spintech, Inc.
Washington, DC, US - Received
- November 5, 2002
- Decision date
- September 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Safetywand Disposable Handpiece cleared by the FDA?
Safetywand Disposable Handpiece (K023722) received a 510(k) decision of Substantially Equivalent on September 2, 2003, 301 days after the submission was received.
What is the product code of K023722?
The FDA product code is EJI – Syringe, Cartridge, a Class II (moderate risk) device regulated under 21 CFR 872.6770.