FDA 510(k) Application Details - K022859

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K022859
Device Name Implant, Endosseous, Root-Form
Applicant STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM, MA 02154 US
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Contact LINDA JALBERT
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 08/28/2002
Decision Date 09/19/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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