COOK Vacuum Pump— 510(k) K160753

Clearance details

Applicant

William A. Cook Australia Pty. , Ltd.

Product code

Code MQG

Device class

Class 2

Regulation

21 CFR 884.6120

Advisory panel

Obstetrics/Gynecology

Date received

2016-03-18

Decision date

2017-06-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Eight Mile Plains, AU

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160753.