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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 K042340
Device Name KASIOS TCP
Applicant
KASIOS BIOMATERIALS
45900 PARSIPPANY COURT
TEMECULA,  CA  92592
Applicant Contact LAETITA BERNARD
Correspondent
KASIOS BIOMATERIALS
45900 PARSIPPANY COURT
TEMECULA,  CA  92592
Correspondent Contact LAETITA BERNARD
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/30/2004
Decision Date 11/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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