Spirit— 510(k) K143696

Substantially Equivalent

Pelton & Crane

FDA 510(k) clearance K143696 for Spirit, Substantially Equivalent on 2015-09-18. Applicant: Pelton & Crane. Device class: 1.

Clearance details

Applicant: Pelton & Crane
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2014-12-24
Decision date: 2015-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, 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.