UMBICUT— 510(k) K000227

Substantially Equivalent

Pollak (Intl.), Ltd.

FDA 510(k) clearance K000227 for UMBICUT, Substantially Equivalent on 2000-04-27. Applicant: Pollak (Intl.), Ltd.. Device class: 2.

Clearance details

Applicant: Pollak (Intl.), Ltd.
Product code: Code HFW
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2000-01-24
Decision date: 2000-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosh Ha'Ayin, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Pollak (Intl.), Ltd.

K810049 — PEDICAT*1981-04-21
K810050 — VECAFIX*1981-03-26
K802009 — FLOWCLAMP CAT.#1011 & 10121980-10-31
K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#11181980-10-31
K802017 — DRESSING CHANGE SET CAT.#910-9301980-10-10

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