MORPHEUS

Syringe, Cartridge

MEIBACH TECH LTDA

The following data is part of a premarket notification filed by Meibach Tech Ltda with the FDA for Morpheus.

Pre-market Notification Details

• Device ID: K082249
• 510k Number: K082249
• Device Name: MORPHEUS
• Classification: Syringe, Cartridge
• Applicant: MEIBACH TECH LTDA 1740 BROADWAY New York, NY 10019
• Contact: Stuart L Friedel
• Correspondent: Stuart L Friedel; MEIBACH TECH LTDA 1740 BROADWAY New York, NY 10019
• Product Code: EJI
• CFR Regulation Number: 872.6770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-08-08
• Decision Date: 2009-12-31