Cleared Traditional

MULTIPURPOSE HANDLING MEDIUM

K121128 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology
Jun 2012
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K121128 is an FDA 510(k) clearance for the MULTIPURPOSE HANDLING MEDIUM, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 6, 2012, 54 days after receiving the submission on April 13, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K121128 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2012
Decision Date June 06, 2012
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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