INFANT HEEL WARMER BY INTCO— 510(k) K053254

Name: FDA 510(k) clearance K053254
Creator: U.S. Food and Drug Administration
Published: 2006-09-19

Substantially Equivalent

Shanghai Intco Medical Supply Co., Ltd.

FDA 510(k) clearance K053254 for INFANT HEEL WARMER BY INTCO, Substantially Equivalent on 2006-09-19. Applicant: Shanghai Intco Medical Supply Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shanghai Intco Medical Supply Co., Ltd.
Product code: Code MPO
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 2005-11-21
Decision date: 2006-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chino, CA, 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.