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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K161704
Device Name Phasor Drill
Applicant
Biotex, Inc.
114 Holmes Rd.
Houston,  TX  77045
Applicant Contact RICHARD WAITE
Correspondent
Phasor Health, LLC
8944 Kirby Dr.
Houston,  TX  77054
Correspondent Contact Ray King
Regulation Number882.4310
Classification Product Code
HBE  
Date Received06/20/2016
Decision Date 12/01/2016
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
Recalls CDRH Recalls
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