FDA 510(k) Application Details - K041651

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K041651
Device Name Implant, Endosseous, Root-Form
Applicant STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact WADE T RUTKOSKIE
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 06/17/2004
Decision Date 09/30/2004
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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