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FDA 510(k) Application Details - K040419
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K040419
Device Name
Filler, Bone Void, Calcium Compound
Applicant
ISOTIS ORTHOBIOLOGICS, INC
PROF. BRONKHORSTLAAN 10-D
P.O. BOX 98
BILTHOVEN 3723 MB NL
Other 510(k) Applications for this Company
Contact
ELIANE SCHUTTE
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/18/2004
Decision Date
03/25/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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