LITTLE ANGELS SWADDLING BLANKET— 510(k) K123411

Name: FDA 510(k) clearance K123411
Creator: U.S. Food and Drug Administration
Published: 2013-03-07

Substantially Equivalent

Bionix Development Corp.

FDA 510(k) clearance K123411 for LITTLE ANGELS SWADDLING BLANKET, Substantially Equivalent on 2013-03-07. Applicant: Bionix Development Corp.. Device class: 2.

Clearance details

Applicant: Bionix Development Corp.
Product code: Code PDH
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2012-11-05
Decision date: 2013-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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