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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K901603
Device Name MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
Applicant
Bivona Medical Technologies
5700 W. 23rd Ave.
Gary,  IN  46406
Applicant Contact HARRY M KAUFMAN
Correspondent
Bivona Medical Technologies
5700 W. 23rd Ave.
Gary,  IN  46406
Correspondent Contact HARRY M KAUFMAN
Regulation Number876.5090
Classification Product Code
KOB  
Date Received03/27/1990
Decision Date 05/04/1990
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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