CERASYS - ZR— 510(k) K042548

Substantially Equivalent

Cerasys, Inc.

FDA 510(k) clearance K042548 for CERASYS - ZR, Substantially Equivalent on 2004-12-03. Applicant: Cerasys, Inc.. Device class: 2.

Clearance details

Applicant: Cerasys, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2004-09-20
Decision date: 2004-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, 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.