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FDA 510(k) Application Details - K060530
Device Classification Name
Teeth, Porcelain
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510(K) Number
K060530
Device Name
Teeth, Porcelain
Applicant
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA, MN 55318 US
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Contact
RACHEL KENNEDY
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Regulation Number
872.3920
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Classification Product Code
ELL
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More FDA Info for this Product Code
Date Received
02/28/2006
Decision Date
05/22/2006
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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