Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray— 510(k) K152951

Name: FDA 510(k) clearance K152951
Creator: U.S. Food and Drug Administration
Published: 2015-12-28

Substantially Equivalent

Paragon Medical, Inc.

FDA 510(k) clearance K152951 for Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray, Substantially Equivalent on 2015-12-28. Applicant: Paragon Medical, Inc.. Device class: 2.

Clearance details

Applicant: Paragon Medical, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2015-10-06
Decision date: 2015-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pierceton, IN, US

Download summary PDF View on FDA.gov ↗

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