FLOWCLAMP CAT.#1011 & 1012— 510(k) K802009

Name: FDA 510(k) clearance K802009
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

Pollak (Intl.), Ltd.

FDA 510(k) clearance K802009 for FLOWCLAMP CAT.#1011 & 1012, Substantially Equivalent on 1980-10-31. Applicant: Pollak (Intl.), Ltd.. Device class: 1.

Clearance details

Applicant: Pollak (Intl.), Ltd.
Product code: Code FKK
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1980-08-20
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K831689 — EMPTY DIALYSATE CONTAINER1983-08-11
K822551 — AMP CAPD UNISPIKE AMINISTRATION SET1982-10-13

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K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#11181980-10-31
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Data sourced from openFDA. This site is unofficial and independent of the FDA.