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FDA 510(k) Application Details - K073342
Device Classification Name
Screw, Fixation, Intraosseous
More FDA Info for this Device
510(K) Number
K073342
Device Name
Screw, Fixation, Intraosseous
Applicant
SALVIN DENTAL SPECIALTIES, INC.
3450 LATROBE DR.
CHARLOTTE, NC 28211 US
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Contact
ROBERT SALVIN
Other 510(k) Applications for this Contact
Regulation Number
872.4880
More FDA Info for this Regulation Number
Classification Product Code
DZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/28/2007
Decision Date
03/26/2008
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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