FDA 510(k) Application Details - K023580

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K023580
Device Name Implant, Endosseous, Root-Form
Applicant STERNGOLD
5 WHITCOMB AVE.
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/24/2002
Decision Date 01/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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