VIVA— 510(k) K011480

Substantially Equivalent

Richter Rubber Technology Sdn. Bhd.

FDA 510(k) clearance K011480 for VIVA, Substantially Equivalent on 2001-05-24. Applicant: Richter Rubber Technology Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Richter Rubber Technology Sdn. Bhd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2001-05-14
Decision date: 2001-05-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Louisville, KY, 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.