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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Shunt System Implantation
510(k) Number K865075
Device Name H-H SUBGALEAL TROCAR
Applicant
HOLTER-HAUSNER INTL.
THIRD AND MILL STREETS
P.O. BOX 100
BRIDGEPORT,  PA  19405
Applicant Contact JOHN R BOLLES
Correspondent
HOLTER-HAUSNER INTL.
THIRD AND MILL STREETS
P.O. BOX 100
BRIDGEPORT,  PA  19405
Correspondent Contact JOHN R BOLLES
Regulation Number882.4545
Classification Product Code
GYK  
Date Received12/29/1986
Decision Date 01/13/1987
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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