H-H ALIMENTATION CATHETERS— 510(k) K821012

Name: FDA 510(k) clearance K821012
Creator: U.S. Food and Drug Administration
Published: 1982-05-28

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K821012 for H-H ALIMENTATION CATHETERS, Substantially Equivalent on 1982-05-28. Applicant: Holter-Hausner Intl.. Device class: 2.

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1982-04-12
Decision date: 1982-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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