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FDA 510(k) Application Details - K962374
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
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510(K) Number
K962374
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
POLYDENTIA USA
1819 SO. MAY ST.
2F
CHICAGO, IL 60608 US
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Contact
ROBERT W BAUER
Other 510(k) Applications for this Contact
Regulation Number
872.3760
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Classification Product Code
EBI
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More FDA Info for this Product Code
Date Received
06/20/1996
Decision Date
07/22/1996
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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