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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, perfusion, kidney, disposable
510(k) Number K891239
Device Name MOP CATHETER
Applicant
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact HARRY M KAUFMAN
Correspondent
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact HARRY M KAUFMAN
Regulation Number876.5880
Classification Product Code
KDL  
Date Received03/07/1989
Decision Date 11/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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