COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400— 510(k) K082939

Name: FDA 510(k) clearance K082939
Creator: U.S. Food and Drug Administration
Published: 2009-09-03

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K082939 for COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400, Substantially Equivalent on 2009-09-03. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2008-10-02
Decision date: 2009-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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