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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Distraction System
510(k) Number K163315
Device Name Internal Distraction - Sterile
Applicant
KLS Martin LP
11201 Saint Johns Industrial Pkwy S
Jacksonville,  FL  32246
Applicant Contact Jennifer Damato
Correspondent
KLS Martin LP
11201 Saint Johns Industrial Pkwy S
Jacksonville,  FL  32246
Correspondent Contact Jennifer Damato
Regulation Number882.5330
Classification Product Code
PBJ  
Date Received11/23/2016
Decision Date 05/05/2017
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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