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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K862484
Device Name HCI Y-CONNECTOR
Applicant
Hospital Concepts, Inc.
2701 W. Alameda Ave., Suite
406
Burbank,  CA  91505
Applicant Contact PRADIP CHOKSI
Correspondent
Hospital Concepts, Inc.
2701 W. Alameda Ave., Suite
406
Burbank,  CA  91505
Correspondent Contact PRADIP CHOKSI
Regulation Number876.5130
Classification Product Code
KOD  
Date Received06/30/1986
Decision Date 09/09/1986
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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