Stern's S250 Nordam
FDA 510(k) K092917 · Cefla S.C.
510(k) numberK092917
Submission
- Device name
- Stern's S250 Nordam
- Applicant
- Cefla S.C.
Ormond Beach, FL, US - Received
- September 22, 2009
- Decision date
- June 24, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Stern's S250 Nordam cleared by the FDA?
Stern's S250 Nordam (K092917) received a 510(k) decision of Substantially Equivalent on June 24, 2010, 275 days after the submission was received.
What is the product code of K092917?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.