TRANQUILITY— 510(k) K843869

Substantially Equivalent

Principle Business Ent.

FDA 510(k) clearance K843869 for TRANQUILITY, Substantially Equivalent on 1984-11-16. Applicant: Principle Business Ent.. Device class: 1.

Clearance details

Applicant: Principle Business Ent.
Product code: Code EYQ
Device class: Class 1
Regulation: 21 CFR 876.5920
Advisory panel: Gastroenterology, Urology
Date received: 1984-10-02
Decision date: 1984-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunbridge, OH, 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.