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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K913490
Device Name PHOENIX BURR HOLE BUTTON, BURR 1
Applicant
Phoenix Bioengineering, Inc.
Third And Mill St.s
P.O. Box 96
Bridgeport,  PA  19405
Applicant Contact HORACE J WILMER
Correspondent
Phoenix Bioengineering, Inc.
Third And Mill St.s
P.O. Box 96
Bridgeport,  PA  19405
Correspondent Contact HORACE J WILMER
Regulation Number882.5250
Classification Product Code
GXR  
Date Received08/06/1991
Decision Date 01/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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