FDA 510(k) Application Details - K050506

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K050506
Device Name Implant, Endosseous, Root-Form
Applicant LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA, MN 55318-3015 US
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Contact RACHEL KENNEDY
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 02/28/2005
Decision Date 04/15/2005
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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