E-Z BREATHERS— 510(k) K953042

Name: FDA 510(k) clearance K953042
Creator: U.S. Food and Drug Administration
Published: 1995-12-08

Substantially Equivalent

E-Z Kare Good Health Systems, Inc.

FDA 510(k) clearance K953042 for E-Z BREATHERS, Substantially Equivalent on 1995-12-08. Applicant: E-Z Kare Good Health Systems, Inc.. Device class: 1.

Clearance details

Applicant: E-Z Kare Good Health Systems, Inc.
Product code: Code LWF
Device class: Class 1
Regulation: 21 CFR 874.3900
Advisory panel: Ear, Nose, Throat
Date received: 1995-06-15
Decision date: 1995-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tavares, FL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.