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FDA 510(k) Application Details - K982927
Device Classification Name
Screw, Fixation, Intraosseous
More FDA Info for this Device
510(K) Number
K982927
Device Name
Screw, Fixation, Intraosseous
Applicant
KINAMED, INC.
2192-C ANCHOR COURT
NEWBURY PARK, CA 91320 US
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Contact
ROBERT BRUCE
Other 510(k) Applications for this Contact
Regulation Number
872.4880
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Classification Product Code
DZL
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More FDA Info for this Product Code
Date Received
08/20/1998
Decision Date
09/08/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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