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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K870660
Device Name H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
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 Number882.5550
Classification Product Code
JXG  
Date Received02/19/1987
Decision Date 05/01/1987
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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