FDA 510(k) Application Details - K990537

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K990537
Device Name Bone Grafting Material, Synthetic
Applicant LUITPOLD PHARMACEUTICALS, INC.
1050 CONNECTICUT AVENUE, N.W.
WASHINGTON, DC 20036-5339 US
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Contact PETER S REICHERTZ
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 02/19/1999
Decision Date 11/19/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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