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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 K040134
Device Name THERILINK BONE VOID FILLER
Applicant
THERICS, INC.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JOHNATHAN S KAHAN
Correspondent
THERICS, INC.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JOHNATHAN S KAHAN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received01/21/2004
Decision Date 03/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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