Ellipse Supplemental Instrument Trays— 510(k) K151594

Name: FDA 510(k) clearance K151594
Creator: U.S. Food and Drug Administration
Published: 2016-01-25

Substantially Equivalent

Ellipse Technologies, Incorporated

FDA 510(k) clearance K151594 for Ellipse Supplemental Instrument Trays, Substantially Equivalent on 2016-01-25. Applicant: Ellipse Technologies, Incorporated. Device class: 2.

Clearance details

Applicant: Ellipse Technologies, Incorporated
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2015-06-12
Decision date: 2016-01-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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