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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, human source
510(k) Number K060332
Device Name ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
Applicant
ISOTIS NV
PROF. BRONKHORSTLAAN 10-D
BILTHOVEN,  NL 3723 MB
Applicant Contact ELIANE SCHUTTE
Correspondent
ISOTIS NV
PROF. BRONKHORSTLAAN 10-D
BILTHOVEN,  NL 3723 MB
Correspondent Contact ELIANE SCHUTTE
Regulation Number872.3930
Classification Product Code
NUN  
Date Received02/09/2006
Decision Date 03/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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