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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K002186
Device Name VASCULAR ASSIST
Applicant
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Applicant Contact AUDREY A WITKO
Correspondent
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Correspondent Contact AUDREY A WITKO
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Codes
JAF   JOM  
Date Received07/20/2000
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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