PEDIATRIC FOLDING WHEELCHAIR— 510(k) K130644

Name: FDA 510(k) clearance K130644
Creator: U.S. Food and Drug Administration
Published: 2013-10-16

Substantially Equivalent

Columbia Medical Mfg, LLC

FDA 510(k) clearance K130644 for PEDIATRIC FOLDING WHEELCHAIR, Substantially Equivalent on 2013-10-16. Applicant: Columbia Medical Mfg, LLC. Device class: 1.

Clearance details

Applicant: Columbia Medical Mfg, LLC
Product code: Code LBE
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2013-03-11
Decision date: 2013-10-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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