ATG/SM-OSA APPLIANCES— 510(k) K130130

Substantially Equivalent

Selane Products, Inc.

FDA 510(k) clearance K130130 for ATG/SM-OSA APPLIANCES, Substantially Equivalent on 2013-08-26. 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: 2013-01-17
Decision date: 2013-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, 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.