Model MS-1 Handpiece
FDA 510(k) K983413 · Parkell, Inc.
510(k) numberK983413
Submission
- Device name
- Model MS-1 Handpiece
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- September 28, 1998
- Decision date
- December 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Model MS-1 Handpiece cleared by the FDA?
Model MS-1 Handpiece (K983413) received a 510(k) decision of Substantially Equivalent on December 21, 1998, 84 days after the submission was received.
What is the product code of K983413?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.