AKRO-SIL PLUS

Catheter, Urological

AKRON CATHETER, INC.

The following data is part of a premarket notification filed by Akron Catheter, Inc. with the FDA for Akro-sil Plus.

Pre-market Notification Details

Device IDK864736
510k NumberK864736
Device Name:AKRO-SIL PLUS
ClassificationCatheter, Urological
Applicant AKRON CATHETER, INC. P.O. BOX 5356 Akron,  OH  44313
ContactMarjorie Skinner
CorrespondentMarjorie Skinner
AKRON CATHETER, INC. P.O. BOX 5356 Akron,  OH  44313
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-04
Decision Date1986-12-24

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