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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 K072764
Device Name KLS MARTIN XTERNAL FIXATOR
Applicant
KLS MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE,  FL  32246
Applicant Contact TOM FAUCETT
Correspondent
KLS MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE,  FL  32246
Correspondent Contact TOM FAUCETT
Regulation Number872.4760
Classification Product Code
MQN  
Date Received09/28/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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