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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Drainage Collection Kit, For Indwelling Catheter
510(k) Number K945258
Device Name CATCO URINARY COLLECTION KIT
Applicant
Catco Medical, Inc.
9010 Foxland Dr.
San Antonio,  TX  78230
Applicant Contact CLYDE N BAKER
Correspondent
Catco Medical, Inc.
9010 Foxland Dr.
San Antonio,  TX  78230
Correspondent Contact CLYDE N BAKER
Regulation Number876.5250
Classification Product Code
FCN  
Date Received10/28/1994
Decision Date 02/16/1995
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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