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FDA 510(k) Application Details - K992623
Device Classification Name
Screw, Fixation, Intraosseous
More FDA Info for this Device
510(K) Number
K992623
Device Name
Screw, Fixation, Intraosseous
Applicant
MITEK PRODUCTS
60 GLACIER DR.
WESTWOOD, MA 02090 US
Other 510(k) Applications for this Company
Contact
PAULA E BULGER
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
08/05/1999
Decision Date
11/02/1999
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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