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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 K870722
Device Name LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
Applicant
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Applicant Contact DEL DONNA
Correspondent
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Correspondent Contact DEL DONNA
Regulation Number876.5820
Classification Product Code
FJK  
Date Received02/05/1987
Decision Date 09/14/1988
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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