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FDA 510(k) Application Details - K050934
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K050934
Device Name
Plate, Bone
Applicant
MEDARTIS, INC.
11234 EL CAMINO REAL, STE 200
SAN DIEGO, CA 92130 US
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Contact
FLOYD G LARSON
Other 510(k) Applications for this Contact
Regulation Number
872.4760
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Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2005
Decision Date
05/05/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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