FDA 510(k), K010139, ZURICH DISTRACTION SYSTEM

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

139 pages (41 of 180 original pages are fully redacted)