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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 K061880
Device Name ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
Applicant
ISOTIS NV
PROF. BRONKHORSTLAAN 10-D
3723 MB
BILTHOVEN,  NL 3723 MB
Applicant Contact ELAINE SCHUTTE
Correspondent
ISOTIS NV
PROF. BRONKHORSTLAAN 10-D
3723 MB
BILTHOVEN,  NL 3723 MB
Correspondent Contact ELAINE SCHUTTE
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received07/03/2006
Decision Date 08/15/2007
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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