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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K032840
Device Name ATRION MEDICAL QL INFLATION DEVICE
Applicant
Atrion Medical Products, Inc.
1426 Curt Francis Rd.
Arab,  AL  35016
Applicant Contact DAN CLARK
Correspondent
Atrion Medical Products, Inc.
1426 Curt Francis Rd.
Arab,  AL  35016
Correspondent Contact DAN CLARK
Regulation Number876.5520
Classification Product Code
KOE  
Subsequent Product Code
MAV  
Date Received09/11/2003
Decision Date 03/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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