FDA 510(k) Application Details - K020645

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K020645
Device Name Implant, Endosseous, Root-Form
Applicant BIOHORIZONS IMPLANT SYSTEMS, INC.
ONE PERIMETER PARK SOUTH
SUITE 230, SOUTH
BIRMINGHAM, AL 35243 US
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Contact DONALD E DALTON
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 02/28/2002
Decision Date 03/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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