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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, straight
510(k) Number K993226
Device Name MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
Applicant
MEMCATH TECHNOLOGIES LLC.
1777 OAKDALE AVE.
WEST ST. PAUL,  MN  55118 -4031
Applicant Contact MARC JAKER
Correspondent
MEMCATH TECHNOLOGIES LLC.
1777 OAKDALE AVE.
WEST ST. PAUL,  MN  55118 -4031
Correspondent Contact MARC JAKER
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Code
KOD  
Date Received09/27/1999
Decision Date 12/10/1999
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
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