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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cranial surgical planning and instrument guides
510(k) Number K182889
Device Name KLS Martin Individual Patient Solutions (IPS) Planning System
Applicant
KLS-Martin L.P.
11201 Saint Johns Industrial Parkway S
Jacksonville,  FL  32246
Applicant Contact Jennifer Damato
Correspondent
KLS-Martin L.P.
11201 Saint Johns Industrial Parkway S
Jacksonville,  FL  32246
Correspondent Contact Katie Rutland
Regulation Number882.4310
Classification Product Code
PPT  
Date Received10/15/2018
Decision Date 07/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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