KOLLMANN URETHRAL DILATOR— 510(k) K841386

Name: FDA 510(k) clearance K841386
Creator: U.S. Food and Drug Administration
Published: 1984-05-09

Substantially Equivalent

Imm Enterprises , Ltd.

FDA 510(k) clearance K841386 for KOLLMANN URETHRAL DILATOR, Substantially Equivalent on 1984-05-09. Applicant: Imm Enterprises , Ltd.. Device class: 2.

Clearance details

Applicant: Imm Enterprises , Ltd.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1984-03-27
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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