FDA 510(k) Application Details - K042730

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K042730
Device Name Bone Grafting Material, Synthetic
Applicant LIFECORE BIOMEDICAL
3515 LYMAN BLVD.
CHASKA, MN 55318 US
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Contact JEREMY HUOTARI
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 10/01/2004
Decision Date 02/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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