KOLPOSKOP KP20005— 510(k) K791279

Substantially Equivalent

Elmed, Inc.

FDA 510(k) clearance K791279 for KOLPOSKOP KP20005, Substantially Equivalent on 1979-09-17. Applicant: Elmed, Inc.. Device class: 2.

Clearance details

Applicant: Elmed, Inc.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 1979-07-10
Decision date: 1979-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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