H-H VENTRICULAR CATHETERS & RESERVOIRS

Shunt, Central Nervous System And Components

HOLTER-HAUSNER INTL.

The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Ventricular Catheters & Reservoirs.

Pre-market Notification Details

Device IDK853361
510k NumberK853361
Device Name:H-H VENTRICULAR CATHETERS & RESERVOIRS
ClassificationShunt, Central Nervous System And Components
Applicant HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport,  PA  19405
ContactJohn R Bolles
CorrespondentJohn R Bolles
HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport,  PA  19405
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-12
Decision Date1985-08-28

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