EI DOWNPAK BARRIER SLEEVES— 510(k) K073369

Name: FDA 510(k) clearance K073369
Creator: U.S. Food and Drug Administration
Published: 2008-02-27

Substantially Equivalent

Hu-Friedy Mfg. Co., Inc.

FDA 510(k) clearance K073369 for EI DOWNPAK BARRIER SLEEVES, Substantially Equivalent on 2008-02-27. Applicant: Hu-Friedy Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: Hu-Friedy Mfg. Co., Inc.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 2007-11-30
Decision date: 2008-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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