Surpasson P5 Newtron
FDA 510(k) K050895 · Satelec
510(k) numberK050895
Submission
- Device name
- Surpasson P5 Newtron
- Applicant
- Satelec
Merignac, Gironde, FR - Received
- April 8, 2005
- Decision date
- April 20, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Surpasson P5 Newtron cleared by the FDA?
Surpasson P5 Newtron (K050895) received a 510(k) decision of Substantially Equivalent on April 20, 2005, 12 days after the submission was received.
What is the product code of K050895?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.