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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K902426
Device Name HEMODIALYSIS SYSTEM AND ACCESSORY
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 Number876.5820
Classification Product Code
FJK  
Date Received05/31/1990
Decision Date 11/20/1990
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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