RLS 9100 RHINO-LARYNGEAL STROBOSCOPE— 510(k) K921184

Name: FDA 510(k) clearance K921184
Creator: U.S. Food and Drug Administration
Published: 1992-05-28

Substantially Equivalent

Kay Elemetrics Corp.

FDA 510(k) clearance K921184 for RLS 9100 RHINO-LARYNGEAL STROBOSCOPE, Substantially Equivalent on 1992-05-28. Applicant: Kay Elemetrics Corp.. Device class: 1.

Clearance details

Applicant: Kay Elemetrics Corp.
Product code: Code EQL
Device class: Class 1
Regulation: 21 CFR 874.4750
Advisory panel: Ear, Nose, Throat
Date received: 1992-03-09
Decision date: 1992-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pine Brook, NJ, US

Download summary PDF View on FDA.gov ↗

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