EMBRYOGEN

Media, Reproductive

ORIGIO A/S

The following data is part of a premarket notification filed by Origio A/s with the FDA for Embryogen.

Pre-market Notification Details

• Device ID: K120136
• 510k Number: K120136
• Device Name: EMBRYOGEN
• Classification: Media, Reproductive
• Applicant: ORIGIO A/S 15696 OAKSTAND ROAD Poway, CA 92064
• Contact: Eric Gruff
• Correspondent: Eric Gruff; ORIGIO A/S 15696 OAKSTAND ROAD Poway, CA 92064
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2012-01-17
• Decision Date: 2012-09-26
• Summary: summary