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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
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