FDA 510(k) Application Details - K010775

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K010775
Device Name Bone Grafting Material, Synthetic
Applicant IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE, OK 73401 US
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Contact M.K. PATTERSON
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 03/14/2001
Decision Date 06/12/2001
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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