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FDA 510(k) Application Details - K051946
Device Classification Name
External Mandibular Fixator And/Or Distractor
More FDA Info for this Device
510(K) Number
K051946
Device Name
External Mandibular Fixator And/Or Distractor
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
MQN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2005
Decision Date
08/22/2005
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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