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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 K051722
Device Name TRICOS T
Applicant
Baxter Healthcare Corp
One Baxter Way
Westlake Village,  CA  91362
Applicant Contact BRIAN L BISHOP
Correspondent
Baxter Healthcare Corp
One Baxter Way
Westlake Village,  CA  91362
Correspondent Contact BRIAN L BISHOP
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/27/2005
Decision Date 11/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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