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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 K033483
Device Name KLS-MARTIN ORTHO ANCHORAGE SYSTEM
Applicant
KLS-Martin L.P.
11239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-Martin L.P.
11239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/04/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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