Bright Guard— 510(k) K181099

Name: FDA 510(k) clearance K181099
Creator: U.S. Food and Drug Administration
Published: 2019-01-18

Substantially Equivalent

Koncept Innovators, LLC

FDA 510(k) clearance K181099 for Bright Guard, Substantially Equivalent on 2019-01-18. Applicant: Koncept Innovators, LLC. Device class: Unclassified.

Clearance details

Applicant: Koncept Innovators, LLC
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-04-26
Decision date: 2019-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Myrtle Beach, SC, US

Download summary PDF View on FDA.gov ↗

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