FDA 510(k) Application Details - K961005

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K961005
Device Name Implant, Endosseous, Root-Form
Applicant GRAHAM & JAMES
2000 M ST., N.W., SUITE 700
WASHINGTON, DC 20036 US
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Contact DANIEL J MANELLI
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 03/12/1996
Decision Date 05/06/1996
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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