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FDA 510(k) Application Details - K030554
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K030554
Device Name
Filler, Bone Void, Calcium Compound
Applicant
SKELETAL KINETICS, LLC
555 13TH ST. N.W.
WASHINGTON, DC 20004 US
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Contact
HOWARD HOLSTEIN
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/21/2003
Decision Date
05/20/2003
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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