SLEEPRIGHT— 510(k) K100545

Name: FDA 510(k) clearance K100545
Creator: U.S. Food and Drug Administration
Published: 2010-06-04

Substantially Equivalent

Power Products, Inc.-Splintek

FDA 510(k) clearance K100545 for SLEEPRIGHT, Substantially Equivalent on 2010-06-04. Applicant: Power Products, Inc.-Splintek. Device class: Unclassified.

Clearance details

Applicant: Power Products, Inc.-Splintek
Product code: Product code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2010-02-26
Decision date: 2010-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, 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.