FDA 510(k) Application Details - K022033

Device Classification Name Plate, Bone

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510(K) Number K022033
Device Name Plate, Bone
Applicant BIOPLATE, INC.
815 CONNECTICUT AVE NW
WASHINGTON, DC 20006-4004 US
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Contact BRUCE F MACKLER
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 06/21/2002
Decision Date 07/19/2002
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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