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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 K033722
Device Name APAPORE BONE GRAFT SUBSTITUTE
Applicant
Apatech , Ltd.
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Apatech , Ltd.
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/26/2003
Decision Date 05/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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