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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 K091729
Device Name ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
Applicant
Etex Corp.
38 Sidney St., 3flr
The Clark Bldg.
Cambridge,  MA  02139
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
Etex Corp.
38 Sidney St., 3flr
The Clark Bldg.
Cambridge,  MA  02139
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number872.3930
Classification Product Code
LYC  
Subsequent Product Code
NUN  
Date Received06/11/2009
Decision Date 12/23/2009
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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