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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K150423
Device Name EXPAZEN
Applicant
Produits Dentaires Pierre Rolland (Acteon Group)
17 Ave. Gustave Eiffel
Zi Du Phare
Merignac,  FR 33708
Applicant Contact GENEVIEVE DE VILLEDON
Correspondent
Acteon, Inc.
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact RICK ROSATI
Classification Product Code
MVL  
Date Received02/19/2015
Decision Date 07/08/2015
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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