P-S MEDICAL CSF ACCESS DEV 15MM/25MM

Port & Catheter, Implanted, Subcutaneous, Intraventricular

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 P-s Medical Csf Access Dev 15mm/25mm.

Pre-market Notification Details

Device IDK833822
510k NumberK833822
Device Name:P-S MEDICAL CSF ACCESS DEV 15MM/25MM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intraventricular
Applicant PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLKG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-02
Decision Date1984-05-25

NIH GUDID Devices

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