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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 K160566
Device Name Cerasorb Ortho Foam
Applicant
Curasan AG
Lindigstrasse 4
Kleinostheim,  DE 63801
Applicant Contact Wolf-Dietrich Hubner
Correspondent
Yes Medical Device Services GmbH
Bahnstrasse 42-46
Friedrichsdorf,  DE 61381
Correspondent Contact Karin Lubbers
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/29/2016
Decision Date 12/02/2016
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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