BlastGen

Media, Reproductive

ORIGIO A/S

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

Pre-market Notification Details

• Device ID: K152932
• 510k Number: K152932
• Device Name: BlastGen
• Classification: Media, Reproductive
• Applicant: ORIGIO A/S KNARDRUPVEJ 2 Malov, DK 2760
• Contact: Tove Kjaer
• Correspondent: Tove Kjaer; ORIGIO A/S KNARDRUPVEJ 2 Malov, DK 2760
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-05
• Decision Date: 2016-02-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
60888937819832	K152932	000
00888937801477	K152932	000