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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 K853362
Device Name H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
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 Received08/12/1985
Decision Date 09/03/1985
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
Recalls CDRH Recalls
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