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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
Predetermined Change
Control Plan Authorized		 No
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