CSF-CARDIAC/PERITONEAL CATHETER

Shunt, Central Nervous System And Components

PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Csf-cardiac/peritoneal Catheter.

Pre-market Notification Details

Device IDK792005
510k NumberK792005
Device Name:CSF-CARDIAC/PERITONEAL CATHETER
ClassificationShunt, Central Nervous System And Components
Applicant PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 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 Received1979-10-05
Decision Date1980-01-16

NIH GUDID Devices

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