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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
Predetermined Change
Control Plan Authorized		 No
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