LUXABITE

Material, Impression

DMG USA, INC.

The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxabite.

Pre-market Notification Details

• Device ID: K013236
• 510k Number: K013236
• Device Name: LUXABITE
• Classification: Material, Impression
• Applicant: DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432
• Contact: Pamela Papineau
• Correspondent: Pamela Papineau; DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-28
• Decision Date: 2001-10-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EDMG1105608	K013236	000