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 IDK871752
510k NumberK871752
Device Name:CSF-CARDIAC/PERITONEAL CATHETER
ClassificationShunt, Central Nervous System And Components
Applicant PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta,  CA  93118
ContactStephen W Laguette
CorrespondentStephen W Laguette
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta,  CA  93118
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-08
Decision Date1987-05-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994908629 K871752 000
00643169010635 K871752 000
00643169010376 K871752 000
00643169507531 K871752 000
00643169497368 K871752 000
00643169483309 K871752 000
00643169483293 K871752 000
00673978249117 K871752 000

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