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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 K201535
Device Name Cerament Bone Void Filler
Applicant
BoneSupport AB
Scheelevagen 19, Ideon Science Park
Lund,  SE SE 223-70
Applicant Contact Blerta Shuka
Correspondent
BoneSupport AB
Scheelevagen 19, Ideon Science Park
Lund,  SE SE 223-70
Correspondent Contact Blerta Shuka
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/08/2020
Decision Date 10/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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