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FDA 510(k) Application Details - K980864
Device Classification Name
Band, Elastic, Orthodontic
More FDA Info for this Device
510(K) Number
K980864
Device Name
Band, Elastic, Orthodontic
Applicant
ORTHO KINETICS CORP.
1611A SOUTH MELROSE DR.
SUITE 16
VISTA, CA 92083-5407 US
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Contact
STEVEN O LUSE
Other 510(k) Applications for this Contact
Regulation Number
872.5410
More FDA Info for this Regulation Number
Classification Product Code
ECI
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More FDA Info for this Product Code
Date Received
03/05/1998
Decision Date
04/20/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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