FDA 510(k) Application Details - K974402

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K974402
Device Name Implant, Endosseous, Root-Form
Applicant VANCOUVER IMPLANT RESOURCES, INC.
2370 MAPLE ST.
VANCOUVER, BC, V6J 3T6 CA
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Contact HAROLD BERGMAN
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 11/21/1997
Decision Date 02/19/1998
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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