Sonopet iQ Sterilization Tray— 510(k) K190667

Substantially Equivalent

Paragon Medical

FDA 510(k) clearance K190667 for Sonopet iQ Sterilization Tray, Substantially Equivalent on 2019-06-13. Applicant: Paragon Medical. Device class: 2.

Clearance details

Applicant: Paragon Medical
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2019-03-15
Decision date: 2019-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pierceton, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.