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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 K051047
Device Name COLLOSS E BONE VOID FILLER
Applicant
Ossacur AG
975 Veronica Springs Rd.
Santa Barbara,  CA  93105
Applicant Contact KRISTI KISTNER
Correspondent
Ossacur AG
975 Veronica Springs Rd.
Santa Barbara,  CA  93105
Correspondent Contact KRISTI KISTNER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/25/2005
Decision Date 03/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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