IRRI-FLO IRRIGATION DELIVERY SYSTEM— 510(k) K891339

Substantially Equivalent

Surgitek

FDA 510(k) clearance K891339 for IRRI-FLO IRRIGATION DELIVERY SYSTEM, Substantially Equivalent on 1989-06-02. Applicant: Surgitek. Device class: 2.

Clearance details

Applicant: Surgitek
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-10
Decision date: 1989-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

Download summary PDF View on FDA.gov ↗

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K941952 — SURGITEK INFUSER1994-05-24
K933260 — HELICAL STONE/FLATWIRE STONE BASKETS1994-01-11

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