FDA 510(k) Application Details - K983563

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K983563
Device Name Implant, Endosseous, Root-Form
Applicant IMCOR
8000 WEST 78TH ST.
SUITE 115
MINNEAPOLIS, MN 55439 US
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Contact ROBERT S URA
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/13/1998
Decision Date 01/11/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K983563


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