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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 K050357
Device Name CAMCERAM TCP
Applicant
Cam Implants B.V.
Zernikedreef 6
Leiden,  NL 2333 CL
Applicant Contact KIM GROENEWEGAN VAN DER WEIJDEN
Correspondent
Cam Implants B.V.
Zernikedreef 6
Leiden,  NL 2333 CL
Correspondent Contact KIM GROENEWEGAN VAN DER WEIJDEN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/14/2005
Decision Date 04/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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