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FDA 510(k) Application Details - K013824
Device Classification Name
Denture, Plastic, Teeth
More FDA Info for this Device
510(K) Number
K013824
Device Name
Denture, Plastic, Teeth
Applicant
DENTAL MANUFACTURING S.P.A
13 RED FOX LN.
LITTLETON, CO 80127 US
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Contact
Kevin Walls
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Regulation Number
872.3590
More FDA Info for this Regulation Number
Classification Product Code
ELM
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More FDA Info for this Product Code
Date Received
11/19/2001
Decision Date
01/30/2002
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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