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FDA 510(k) Application Details - K133907
Device Classification Name
Driver, Wire, And Bone Drill, Manual
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510(K) Number
K133907
Device Name
Driver, Wire, And Bone Drill, Manual
Applicant
MEDICAL MODELING INC.
555 THIRTEENTH STREET NW
WASHINGTON, DC 20004 US
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Contact
JONATHAN S KAHAN
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Regulation Number
872.4120
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Classification Product Code
DZJ
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More FDA Info for this Product Code
Date Received
12/23/2013
Decision Date
01/22/2014
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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