Cleared Special

Sydney IVF Culture Oil

K170257 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Feb 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K170257 is an FDA 510(k) clearance for the Sydney IVF Culture Oil, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on February 24, 2017, 28 days after receiving the submission on January 27, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K170257 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2017
Decision Date February 24, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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