FDA 510(k) Application Details - K073461

Device Classification Name Implant, Endosseous, Orthodontic

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510(K) Number K073461
Device Name Implant, Endosseous, Orthodontic
Applicant M.I.S. IMPLANTS TECHNOLOGIES LTD.
P.O.B. 110
SHLOMI INDUSTRIAL ZONE
SHLOMI 22832 IL
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Contact IMAN KHORSHID
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Regulation Number 872.3640

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Classification Product Code OAT
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Date Received 12/10/2007
Decision Date 01/25/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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