FDA 510(k) Application Details - K945847

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K945847
Device Name Implant, Endosseous, Root-Form
Applicant FRIATEC MEDICAL INC., USA
9229 CRANFORD DR.
POTOMAC, MD 20854 US
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Contact ROBERT J SLOMOFF
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 11/30/1994
Decision Date 03/15/1996
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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