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FDA 510(k) Application Details - K100510
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K100510
Device Name
Cement, Dental
Applicant
DOXA AB
AXEL JOHANSSONS, GATA 4-6
UPPSALA SE-754 51 SE
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Contact
MARGARETH JORVID
Other 510(k) Applications for this Contact
Regulation Number
872.3275
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Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
02/22/2010
Decision Date
03/25/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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