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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 St., NW
Washington,  DC  20004
Applicant Contact JOHNATHAN S KAHAN
Correspondent
Therics, Inc.
555 13th St., 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
Predetermined Change
Control Plan Authorized		 No
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