C CHANGE SOLUTION WARMER— 510(k) K051819

Name: FDA 510(k) clearance K051819
Creator: U.S. Food and Drug Administration
Published: 2005-08-15

Substantially Equivalent

C Change Surgical, LLC

FDA 510(k) clearance K051819 for C CHANGE SOLUTION WARMER, Substantially Equivalent on 2005-08-15. Applicant: C Change Surgical, LLC. Device class: 1.

Clearance details

Applicant: C Change Surgical, LLC
Product code: Code LHC
Device class: Class 1
Regulation: 21 CFR 890.5950
Advisory panel: Physical Medicine
Date received: 2005-07-05
Decision date: 2005-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, 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.