CLIMAX— 510(k) K991049

Substantially Equivalent

Medilatex Sdn. Bhd.

FDA 510(k) clearance K991049 for CLIMAX, Substantially Equivalent on 1999-06-15. Applicant: Medilatex Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Medilatex Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1999-03-30
Decision date: 1999-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kulai, Johor, MY

Download summary PDF View on FDA.gov ↗

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