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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K040891
Device Name KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
Original Applicant
KLS-MARTIN L.P.
11239-1 st. john's ind. pkwy.
south
jacksonville,  FL  32246
Original Contact jennifer damato
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/05/2004
Decision Date 05/28/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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