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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 K971687
Device Name HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
Applicant
National Medical Care, Inc.
2 Volvo Dr.
Rockleigh,  NJ  07647
Applicant Contact DEBRA L BING
Correspondent
National Medical Care, Inc.
2 Volvo Dr.
Rockleigh,  NJ  07647
Correspondent Contact DEBRA L BING
Regulation Number876.5820
Classification Product Code
FJK  
Date Received05/02/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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