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FDA 510(k), K162594, Craniomaxillofacial Distraction System (CMFD)
FDA 510(k), K162594, Craniomaxillofacial Distraction System (CMFD)
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510(K) Number: K162594
Device Name: Craniomaxillofacial Distraction System (CMFD)
Manufacturer: NICHOLAS FOUNTOULAKIS
Device Classification Name: External Mandibular Fixator And/Or Distractor
Regulation Number: MQN
Classification Product Code: KXA
Date Received: 09/16/2016
Decision Date: 05/08/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Craniomaxillofacial Distraction System (CMFD)
Manufacturer: NICHOLAS FOUNTOULAKIS
Device Classification Name: External Mandibular Fixator And/Or Distractor
Regulation Number: MQN
Classification Product Code: KXA
Date Received: 09/16/2016
Decision Date: 05/08/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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