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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 K070784
Device Name INION BIORESTORE
Applicant
Inion OY
Laakarinkatu 2
Tampere,  FI 33520
Applicant Contact KATI MARTINEN
Correspondent
Inion OY
Laakarinkatu 2
Tampere,  FI 33520
Correspondent Contact Kati Marttinen
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/21/2007
Decision Date 07/24/2007
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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