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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name external mandibular fixator and/or distractor
510(k) Number K000580
Device Name ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
Applicant
KLS-MARTIN L.P.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Applicant Contact ART WARD
Correspondent
KLS-MARTIN L.P.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Correspondent Contact ART WARD
Regulation Number872.4760
Classification Product Code
MQN  
Date Received02/22/2000
Decision Date 07/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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