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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
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