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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K161318
Device Name Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
Applicant
TEDAN SURGICAL INNOVATIONS LLC
12615 W. AIRPORT BLVD, SUITE 200
SUGAR LAND,  TX  77478
Applicant Contact John Willis
Correspondent
TEDAN SURGICAL INNOVATIONS LLC
12615 W. AIRPORT BLVD, SUITE 200
SUGAR LAND,  TX  77478
Correspondent Contact John Willis
Regulation Number882.4800
Classification Product Code
GZT  
Date Received05/11/2016
Decision Date 03/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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