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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K922567
Device Name LOW PROFILE CATHETER
Applicant
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact J BROZOWSKI
Correspondent
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact J BROZOWSKI
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/01/1992
Decision Date 11/21/1995
Decision Substantially Equivalent - Kit (SESK)
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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