P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR

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 P-s Medical Csf-flow Control Valve-bur.

Pre-market Notification Details

Device IDK831678
510k NumberK831678
Device Name:P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
ClassificationShunt, Central Nervous System And Components
Applicant PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-23
Decision Date1983-06-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00643169466340 K831678 000
00763000467401 K831678 000

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