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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 K101718
Device Name OSSEOCONDUCT
Applicant
STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC
590 FARRINGTON HWY., #524
SUITE 132
KAPOLEI,  HI  96707
Applicant Contact GREGORY G STEINER
Correspondent
STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC
590 FARRINGTON HWY., #524
SUITE 132
KAPOLEI,  HI  96707
Correspondent Contact GREGORY G STEINER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/18/2010
Decision Date 10/26/2010
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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