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FDA 510(k), K010139, ZURICH DISTRACTION SYSTEM
FDA 510(k), K010139, ZURICH DISTRACTION SYSTEM
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510(K) Number: K010139
Device Name: ZURICH DISTRACTION SYSTEM
Manufacturer: KLS-MARTIN L.P.
Device Classification Name: external mandibular fixator and/or distractor
Regulation Number: 872.4760
Classification Product Code: MQN
Date Received: 01/17/2001
Decision Date: 06/29/2001
Regulation Medical Specialty: Dental
Device Name: ZURICH DISTRACTION SYSTEM
Manufacturer: KLS-MARTIN L.P.
Device Classification Name: external mandibular fixator and/or distractor
Regulation Number: 872.4760
Classification Product Code: MQN
Date Received: 01/17/2001
Decision Date: 06/29/2001
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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