LUBRICANO STERILE GEL— 510(k) K081990

Substantially Equivalent

Farco Pharma GmbH

FDA 510(k) clearance K081990 for LUBRICANO STERILE GEL, Substantially Equivalent on 2008-12-05. Applicant: Farco Pharma GmbH. Device class: 2.

Clearance details

Applicant: Farco Pharma GmbH
Product code: Code FHX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2008-07-14
Decision date: 2008-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHX

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K935548 — CATHEJELL S STERILE LUBRICATING JELLY1994-03-30
K912132 — OPERAND LUBRICATING JELLY1991-08-07
K780386 — K-Y LUBRICATING JELLY1978-04-13
K771364 — LUBE JEL1977-08-02

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