FDA 510(k) Application Details - K090871

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K090871
Device Name Filler, Bone Void, Calcium Compound
Applicant BONESUPPORT AB
SCHEELEVAGEN 19A
IDEON SCIENCE PARK
LUND SE 223-70 SE
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Contact ANN-CHRISTINE PROVOOST
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 03/30/2009
Decision Date 09/04/2009
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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