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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 K102812
Device Name GAMMA-BSM; BETA-BSM; EQUIVABONE
Applicant
ETEX CORPORATION
38 SIDNEY STREET
CAMBRIDGE,  MA  02139
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
ETEX CORPORATION
38 SIDNEY STREET
CAMBRIDGE,  MA  02139
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number872.3930
Classification Product Code
LYC  
Subsequent Product Code
NUN  
Date Received09/28/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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