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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K082286
Device Name BIOACTYS
Applicant
Graftys
415 Rue Charles Nicolas Ledoux
Eiffel Park Bat D
Aix En Provence,  FR 13854
Applicant Contact ANTHONY LE NAOUR
Correspondent
Graftys
415 Rue Charles Nicolas Ledoux
Eiffel Park Bat D
Aix En Provence,  FR 13854
Correspondent Contact ANTHONY LE NAOUR
Regulation Number872.3930
Classification Product Code
LYC  
Date Received08/11/2008
Decision Date 02/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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