Cleared Traditional

SYDNEY IVF CULTURE OIL

K022002 · Cook Urological, Inc. · Obstetrics & Gynecology
Aug 2002
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K022002 is an FDA 510(k) clearance for the SYDNEY IVF CULTURE OIL, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on August 12, 2002, 54 days after receiving the submission on June 19, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K022002 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2002
Decision Date August 12, 2002
Days to Decision 54 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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