RES-Q INFANT WEDGE AND SLING— 510(k) K090284

Name: FDA 510(k) clearance K090284
Creator: U.S. Food and Drug Administration
Published: 2009-06-05

Substantially Equivalent

Cr Enterprises, LLC

FDA 510(k) clearance K090284 for RES-Q INFANT WEDGE AND SLING, Substantially Equivalent on 2009-06-05. Applicant: Cr Enterprises, LLC. Device class: 1.

Clearance details

Applicant: Cr Enterprises, LLC
Product code: Code FRP
Device class: Class 1
Regulation: 21 CFR 880.5680
Advisory panel: General Hospital
Date received: 2009-02-05
Decision date: 2009-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frisco, TX, 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.