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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 K113049
Device Name SOCKET GRAFT
Applicant
Steiner Laboratories
590 Farrington Hwy., #524
Suite 132
Kapolei,  HI  96707
Applicant Contact GREGORY G STEINER
Correspondent
Steiner Laboratories
590 Farrington Hwy., #524
Suite 132
Kapolei,  HI  96707
Correspondent Contact GREGORY G STEINER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/13/2011
Decision Date 01/27/2012
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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