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FDA 510(k) Application Details - K992609
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
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510(K) Number
K992609
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
KAY SEE DENTAL MFG. CO.
124 EAST MISSOURI AVE.
KANSAS CITY, MO 64106-1294 US
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Contact
CLARK SMITH
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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
08/04/1999
Decision Date
09/22/1999
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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