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FDA 510(k) Application Details - K121502
Device Classification Name
External Mandibular Fixator And/Or Distractor
More FDA Info for this Device
510(K) Number
K121502
Device Name
External Mandibular Fixator And/Or Distractor
Applicant
SYNTHES INC
1301 Goshen Parkway
West Chester, PA 19380 US
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Contact
ALAN T HALEY
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
MQN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/21/2012
Decision Date
08/23/2012
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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