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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K150056
Device Name Luxisse+
Applicant
Heany Industries, Inc.
249 Briarwood Ln.
Scottsville,  NY  14546
Applicant Contact Cliff Rabidoux
Correspondent
Emergo Group
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Carrie Hetrick
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/12/2015
Decision Date 05/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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