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FDA 510(k) Application Details - K080220
Device Classification Name
Drill, Bone, Powered
More FDA Info for this Device
510(K) Number
K080220
Device Name
Drill, Bone, Powered
Applicant
ITALIA MEDICA S.R.L.
110 E. GRANADA BLVD. SUITE 207
ORMOND BEACH, FL 32176 US
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Contact
BERTHOIN CLAUDE
Other 510(k) Applications for this Contact
Regulation Number
872.4120
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Classification Product Code
DZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2008
Decision Date
07/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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