CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET

Catheter, Suprapubic (and Accessories)

BURRON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Cystofix Suprapubic Bladder Drain Set.

Pre-market Notification Details

Device IDK813084
510k NumberK813084
Device Name:CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
ClassificationCatheter, Suprapubic (and Accessories)
Applicant BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOB  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-02
Decision Date1981-12-31

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