Cleared Traditional

COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS

K082363 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Apr 2009
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K082363 is an FDA 510(k) clearance for the COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, Qld, AU). The FDA issued a Cleared decision on April 29, 2009, 254 days after receiving the submission on August 18, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K082363 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2008
Decision Date April 29, 2009
Days to Decision 254 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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