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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K000767
Device Name MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
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
KNY  
Date Received03/09/2000
Decision Date 06/05/2000
Decision Substantially Equivalent (SESE)
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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