JANSEN-ANDERSON INSEMINATION SET

Cannula, Intrauterine Insemination

COOK OB/GYN

The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Jansen-anderson Insemination Set.

Pre-market Notification Details

Device IDK914150
510k NumberK914150
Device Name:JANSEN-ANDERSON INSEMINATION SET
ClassificationCannula, Intrauterine Insemination
Applicant COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer,  IN  47460
ContactMichelle Young
CorrespondentMichelle Young
COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer,  IN  47460
Product CodeMFD  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-16
Decision Date1992-09-02

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