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FDA 510(k) Application Details - K020645
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
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More FDA Info for this Product Code
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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