SurgeoBite— 510(k) K172978

Substantially Equivalent

Surgovations, LLC

FDA 510(k) clearance K172978 for SurgeoBite, Substantially Equivalent on 2017-12-22. Applicant: Surgovations, LLC. Device class: 2.

Clearance details

Applicant: Surgovations, LLC
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 2017-09-27
Decision date: 2017-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Forsyth, GA, 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.