ENTHERMO IRRIGATION UNIT— 510(k) K863615

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K863615 for ENTHERMO IRRIGATION UNIT, Substantially Equivalent on 1986-12-16. Applicant: Jedmed Instrument Co.. Device class: 1.

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code ETP
Device class: Class 1
Regulation: 21 CFR 874.1800
Advisory panel: Ear, Nose, Throat
Date received: 1986-09-16
Decision date: 1986-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.