K181099

Substantially Equivalent

Bright Guard

Applicant: Koncept Innovators, LLC
Product code: OBR
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 ↗

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