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FDA 510(k) Application Details - K091252
Device Classification Name
Drill, Bone, Powered
More FDA Info for this Device
510(K) Number
K091252
Device Name
Drill, Bone, Powered
Applicant
SATELEC
124 GAITHER DRIVE
SUITE 140
MT. LAUREL, NJ 08054 US
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Contact
RICK ROSATI
Other 510(k) Applications for this Contact
Regulation Number
872.4120
More FDA Info for this Regulation Number
Classification Product Code
DZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/29/2009
Decision Date
07/22/2009
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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