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FDA 510(k) Application Details - K060507
Device Classification Name
Denture, Plastic, Teeth
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510(K) Number
K060507
Device Name
Denture, Plastic, Teeth
Applicant
VALPLAST INTL. CORP.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact
MARY MCNAMARA-CULLINANE
Other 510(k) Applications for this Contact
Regulation Number
872.3590
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Classification Product Code
ELM
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More FDA Info for this Product Code
Date Received
02/27/2006
Decision Date
04/07/2006
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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