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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K032413
Device Name KLS-MARTIN STERNAL PLATING 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 Number888.3030
Classification Product Code
HRS  
Date Received08/05/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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