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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
Applicant Contact MARK GAINOR
Correspondent
Gainor Medical Europe, Ltd.
P.O. Box 353
Mcdonough,  GA  30253
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
Predetermined Change
Control Plan Authorized		 No
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