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FDA 510(k) Application Details - K121282
Device Classification Name
More FDA Info for this Device
510(K) Number
K121282
Device Name
MICROLUX/DL MICROLUX/BLU BIO/SCREEN
Applicant
ADDENT, INC.
43 MIRY BROOK RD.
DANBURY, CT 06810 US
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Contact
JOSHUA FRIEDMAN
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Regulation Number
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Classification Product Code
NXV
Other 510(k) Applications for this Device
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Date Received
04/30/2012
Decision Date
07/24/2012
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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