Luxisse+

Powder, Porcelain

HEANY INDUSTRIES INC

The following data is part of a premarket notification filed by Heany Industries Inc with the FDA for Luxisse+.

Pre-market Notification Details

• Device ID: K150056
• 510k Number: K150056
• Device Name: Luxisse+
• Classification: Powder, Porcelain
• Applicant: HEANY INDUSTRIES INC 249 BRIARWOOD LANE Scottsville, NY 14546
• Contact: Cliff Rabidoux
• Correspondent: Carrie Hetrick; EMERGO GROUP 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-12
• Decision Date: 2015-05-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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