QUALIS

Labware, Assisted Reproduction

MENICON CO., LTD. NEW BUSINESS DIVISION

The following data is part of a premarket notification filed by Menicon Co., Ltd. New Business Division with the FDA for Qualis.

Pre-market Notification Details

• Device ID: K133295
• 510k Number: K133295
• Device Name: QUALIS
• Classification: Labware, Assisted Reproduction
• Applicant: MENICON CO., LTD. NEW BUSINESS DIVISION 4050 OLSON MEMORIAL HWY, SUITE 450 Minneapolis, MN 55422
• Contact: Marcia Palma
• Correspondent: Marcia Palma; MENICON CO., LTD. NEW BUSINESS DIVISION 4050 OLSON MEMORIAL HWY, SUITE 450 Minneapolis, MN 55422
• Product Code: MQK
• CFR Regulation Number: 884.6160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-25
• Decision Date: 2014-06-18
• Summary: summary