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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K191028
Device Name KLS Martin Individual Patient Solutions
Applicant
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S.
Jacksonville,  FL  32246
Applicant Contact Jennifer Damato
Correspondent
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S.
Jacksonville,  FL  32246
Correspondent Contact Katie Rutland
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/18/2019
Decision Date 11/22/2019
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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