L- OVC— 510(k) K162677

Substantially Equivalent

Rhondium, Ltd.

FDA 510(k) clearance K162677 for L- OVC, Substantially Equivalent on 2016-12-21. Applicant: Rhondium, Ltd.. Device class: 2.

Clearance details

Applicant: Rhondium, Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2016-09-26
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Katikati, NZ

Download summary PDF View on FDA.gov ↗

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