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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K140088
Device Name PHANTOM XL INSULATED DILATORS
Applicant
TEDAN SURGICAL INNOVATIONS, LLC
12615 W AIRPORT BLVD, SUITE 200
SUGAR LAND,  TX  77478
Applicant Contact JOANN(DIONICIA) REBLANDO
Correspondent
TEDAN SURGICAL INNOVATIONS, LLC
12615 W AIRPORT BLVD, SUITE 200
SUGAR LAND,  TX  77478
Correspondent Contact JOANN(DIONICIA) REBLANDO
Regulation Number874.1820
Classification Product Code
PDQ  
Date Received01/14/2014
Decision Date 09/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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