Cleared Traditional

Sydney IVF Hyaluronidase

K151367 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Jan 2016
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K151367 is an FDA 510(k) clearance for the Sydney IVF Hyaluronidase, 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 January 27, 2016, 251 days after receiving the submission on May 21, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K151367 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2015
Decision Date January 27, 2016
Days to Decision 251 days
Submission Type Traditional
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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