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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K090242
FOIA Releasable 510(k) K090242
Device Name GAMMA-BSM, BETA-BSM
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 Number888.3045
Classification Product Code
MQV  
Date Received02/02/2009
Decision Date 02/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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