EASY-JET DEVICE— 510(k) K972383

Name: FDA 510(k) clearance K972383
Creator: U.S. Food and Drug Administration
Published: 1999-11-23

Substantially Equivalent

A.Stein - Regulatory Affairs Consulting

FDA 510(k) clearance K972383 for EASY-JET DEVICE, Substantially Equivalent on 1999-11-23. Applicant: A.Stein - Regulatory Affairs Consulting. Device class: 2.

Clearance details

Applicant: A.Stein - Regulatory Affairs Consulting
Product code: Code KLZ
Device class: Class 2
Regulation: 21 CFR 874.3850
Advisory panel: Ear, Nose, Throat
Date received: 1997-06-26
Decision date: 1999-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot Shomron 44853, IL

Download summary PDF View on FDA.gov ↗

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