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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 K903021
Device Name NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630
Applicant
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Applicant Contact WILLIAM MATHEWS
Correspondent
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Correspondent Contact WILLIAM MATHEWS
Regulation Number876.5820
Classification Product Code
FJK  
Date Received07/11/1990
Decision Date 08/14/1990
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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