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FDA 510(k) Application Details - K182789
Device Classification Name
Driver, Wire, And Bone Drill, Manual
More FDA Info for this Device
510(K) Number
K182789
Device Name
Driver, Wire, And Bone Drill, Manual
Applicant
KLS-Martin L.P.
11201 Saint Johns Industrial Parkway S
Jacksonville, FL 32246 US
Other 510(k) Applications for this Company
Contact
Jennifer Damato
Other 510(k) Applications for this Contact
Regulation Number
872.4120
More FDA Info for this Regulation Number
Classification Product Code
DZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2018
Decision Date
03/11/2019
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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