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FDA 510(k) Application Details - K092855
Device Classification Name
Screw, Fixation, Intraosseous
More FDA Info for this Device
510(K) Number
K092855
Device Name
Screw, Fixation, Intraosseous
Applicant
MILTEX, INC.
589 DAVIES DR.
YORK, PA 17402 US
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Contact
JENNIFER BOSLEY
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
09/16/2009
Decision Date
12/29/2009
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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