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FDA 510(k) Application Details - K140146
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
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510(K) Number
K140146
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
WHIP MIX CORP.
361 FARMINGTON AVE
LOUISVILLE, KY 40217 US
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Contact
JOHN WATERS
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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
01/22/2014
Decision Date
04/29/2014
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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