FOG CONTROL, LENS FOG REDUCTION DEVICE— 510(k) K932300

Name: FDA 510(k) clearance K932300
Creator: U.S. Food and Drug Administration
Published: 1993-09-17

Substantially Equivalent

Highpoint Medical Corp.

FDA 510(k) clearance K932300 for FOG CONTROL, LENS FOG REDUCTION DEVICE, Substantially Equivalent on 1993-09-17. Applicant: Highpoint Medical Corp.. Device class: 2.

Clearance details

Applicant: Highpoint Medical Corp.
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-05-12
Decision date: 1993-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

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