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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name collector, urine, (and accessories) for indwelling catheter
510(k) Number K902417
Device Name BAG, URINE
Applicant
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Applicant Contact MARK GAINOR
Correspondent
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Correspondent Contact MARK GAINOR
Regulation Number876.5250
Classification Product Code
KNX  
Date Received05/31/1990
Decision Date 07/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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