K190930

Substantially Equivalent

SmarTemp X1

Applicant: Parkell, Inc.
Product code: EBG
Advisory panel: Dental
Date received: 2019-04-10
Decision date: 2019-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgewood, NY, US

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