INFANT SLEEP BEANIE— 510(k) K082367

Substantially Equivalent

Life Innovations, LLC

FDA 510(k) clearance K082367 for INFANT SLEEP BEANIE, Substantially Equivalent on 2009-06-12. Applicant: Life Innovations, LLC. Device class: 1.

Clearance details

Applicant: Life Innovations, LLC
Product code: Code FRP
Device class: Class 1
Regulation: 21 CFR 880.5680
Advisory panel: General Hospital
Date received: 2008-08-18
Decision date: 2009-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellington, CO, 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.