NELATON CATHETER

Catheter, Urological

AMERICAN HOSPITAL SUPPLY CORP.

The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Nelaton Catheter.

Pre-market Notification Details

Device IDK792038
510k NumberK792038
Device Name:NELATON CATHETER
ClassificationCatheter, Urological
Applicant AMERICAN HOSPITAL SUPPLY CORP. 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 Received1979-10-12
Decision Date1979-11-13

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