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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K895244
Device Name MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
Applicant
National Medical Care, Medical Products Div., Inc.
Reservoir Pl.,
1601 Trapelo Rd.
Waltham,  MA  02154
Applicant Contact BERGER, PHD
Correspondent
National Medical Care, Medical Products Div., Inc.
Reservoir Pl.,
1601 Trapelo Rd.
Waltham,  MA  02154
Correspondent Contact BERGER, PHD
Regulation Number876.5820
Classification Product Code
KOC  
Date Received08/21/1989
Decision Date 02/12/1990
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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