FDA 510(k) Application Details - K972842

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K972842
Device Name Bone Grafting Material, Synthetic
Applicant INTERPORE INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact DAVID P BALDING
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 08/01/1997
Decision Date 10/30/1997
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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