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KLS-Martin L.P.
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ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 is an FDA 510(k)-cleared medical device (K000580) manufactured by KLS-Martin L.P.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 2000. Regulation: 8.