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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K923538
Device Name MON-A-THERM FOLEY KIT
Applicant
MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Applicant Contact JEFFERY W BIGGERS
Correspondent
MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Correspondent Contact JEFFERY W BIGGERS
Regulation Number876.5130
Classification Product Code
FCM  
Date Received07/16/1992
Decision Date 05/27/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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