FDA 510(k) Application Details - K973049

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K973049
Device Name Implant, Endosseous, Root-Form
Applicant IMCOR
5763 LONG BRAKE CIR.
EDINA, 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 08/15/1997
Decision Date 11/13/1997
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



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