ISM1+, IMS2+, AND UTM+— 510(k) K030490

Substantially Equivalent

Medicult A/S

FDA 510(k) clearance K030490 for ISM1+, IMS2+, AND UTM+, Substantially Equivalent on 2003-08-20. Applicant: Medicult A/S. Device class: 2.

Clearance details

Applicant: Medicult A/S
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2003-02-14
Decision date: 2003-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.