ATRION MEDICAL QL INFLATION DEVICE

Dilator, Urethral

ATRION MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Atrion Medical Ql Inflation Device.

Pre-market Notification Details

Device IDK032840
510k NumberK032840
Device Name:ATRION MEDICAL QL INFLATION DEVICE
ClassificationDilator, Urethral
Applicant ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab,  AL  35016
ContactDan Clark
CorrespondentDan Clark
ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab,  AL  35016
Product CodeKOE  
CFR Regulation Number876.5520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-11
Decision Date2004-03-03
Summary:summary

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