NON-RETENTION ENEMA SYSTEM— 510(k) K781923

Name: FDA 510(k) clearance K781923
Creator: U.S. Food and Drug Administration
Published: 1979-08-03

Substantially Equivalent

Hudson Kendale Assoc., Inc.

FDA 510(k) clearance K781923 for NON-RETENTION ENEMA SYSTEM, Substantially Equivalent on 1979-08-03. Applicant: Hudson Kendale Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Hudson Kendale Assoc., Inc.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1978-11-16
Decision date: 1979-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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