INTERMITTENT URETHRAL CATHETER TRAY

Catheter, Urological

SEAMLESS HOSPITAL PRODUCTS CO.

The following data is part of a premarket notification filed by Seamless Hospital Products Co. with the FDA for Intermittent Urethral Catheter Tray.

Pre-market Notification Details

Device IDK841769
510k NumberK841769
Device Name:INTERMITTENT URETHRAL CATHETER TRAY
ClassificationCatheter, Urological
Applicant SEAMLESS HOSPITAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-30
Decision Date1984-08-24

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