H-H BURR HOLE CATHETER SUPPORT

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 Burr Hole Catheter Support.

Pre-market Notification Details

Device IDK820311
510k NumberK820311
Device Name:H-H BURR HOLE CATHETER SUPPORT
ClassificationShunt, Central Nervous System And Components
Applicant HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-05
Decision Date1982-02-24

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