SML-OSA2 Appliances— 510(k) K162816

Substantially Equivalent

Selane Products, Inc.

FDA 510(k) clearance K162816 for SML-OSA2 Appliances, Substantially Equivalent on 2017-07-27. Applicant: Selane Products, Inc.. Device class: 2.

Clearance details

Applicant: Selane Products, Inc.
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2016-10-06
Decision date: 2017-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, 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.