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FDA 510(k) Application Details - K181504
Device Classification Name
External Mandibular Fixator And/Or Distractor
More FDA Info for this Device
510(K) Number
K181504
Device Name
External Mandibular Fixator And/Or Distractor
Applicant
Stryker
750 Trade Centre Way - Suite 200
Portage, MI 49002 US
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Contact
Gregory Gohl
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
06/07/2018
Decision Date
09/11/2018
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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