PALEX IRRIGATION SET— 510(k) K904586

Substantially Equivalent

Palex Intl. SA

FDA 510(k) clearance K904586 for PALEX IRRIGATION SET, Substantially Equivalent on 1990-12-28. Applicant: Palex Intl. SA. Device class: 2.

Clearance details

Applicant: Palex Intl. SA
Product code: Code EXD
Device class: Class 2
Regulation: 21 CFR 876.5895
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-09
Decision date: 1990-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spain, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXD

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K840268 — IRRIGATION SYSTEM1984-04-05
K832299 — VISI-FLOW IRRIGATOR1983-08-26

More clearances from Palex Intl. SA

K905108 — CONTORNO(R), MODELS E AND ST1991-02-04
K903224 — EPISENSOR1990-12-24
K902642 — CONTORNO (TM)1990-08-07
K901680 — BAUMAN RIGID LARYNGOSCOPE1990-07-12

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