EMBRYOGLUE

Media, Reproductive

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Embryoglue.

Pre-market Notification Details

• Device ID: K031015
• 510k Number: K031015
• Device Name: EMBRYOGLUE
• Classification: Media, Reproductive
• Applicant: VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg, SE Se-412 63
• Contact: Nina Arvidsson
• Correspondent: Nina Arvidsson; VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg, SE Se-412 63
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-03-31
• Decision Date: 2003-06-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07350025910048	K031015	000
07350025910901	K031015	000