DENOVO TEDDY GEL INFANT HEEL WARMER— 510(k) K103549

Name: FDA 510(k) clearance K103549
Creator: U.S. Food and Drug Administration
Published: 2011-04-08

Substantially Equivalent

Denovo Products, LLC

FDA 510(k) clearance K103549 for DENOVO TEDDY GEL INFANT HEEL WARMER, Substantially Equivalent on 2011-04-08. Applicant: Denovo Products, LLC. Device class: 1.

Clearance details

Applicant: Denovo Products, LLC
Product code: Code MPO
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 2010-12-03
Decision date: 2011-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, 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.