Double Lumen Ovum Aspiration Needles— 510(k) K171611

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K171611 for Double Lumen Ovum Aspiration Needles, Substantially Equivalent on 2017-12-15. Applicant: William A. Cook Australia Pty. , Ltd.. Device class: 2.

Clearance details

Applicant
William A. Cook Australia Pty. , Ltd.
Product code
Code MQE
Device class
Class 2
Regulation
21 CFR 884.6100
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Eight Mile Plains, AU
Download summary PDFView on FDA.gov ↗

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