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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K903340
Device Name STERILE URETHRAL CATHETER PROCEDURE KITS
Applicant
SUPERIOR HEALTHCARE GROUP, INC.
CUMBERLAND INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Applicant Contact MAUREEN MCCABE
Correspondent
SUPERIOR HEALTHCARE GROUP, INC.
CUMBERLAND INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Correspondent Contact MAUREEN MCCABE
Regulation Number876.5130
Classification Product Code
FCM  
Date Received07/25/1990
Decision Date 10/04/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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