CATHETER, NATURAL LATEX URETHRAL

Catheter, Urological

AKRON CATHETER, INC.

The following data is part of a premarket notification filed by Akron Catheter, Inc. with the FDA for Catheter, Natural Latex Urethral.

Pre-market Notification Details

Device IDK760440
510k NumberK760440
Device Name:CATHETER, NATURAL LATEX URETHRAL
ClassificationCatheter, Urological
Applicant AKRON CATHETER, INC. 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 Received1976-08-16
Decision Date1976-10-20

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