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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 K031091
Device Name VTI 20 MHZ GATED DOPPLER
Applicant
VASCULAR TECHNOLOGY INCORPORATED
175 CABOT ST.
LOWELL,  MA  01854
Applicant Contact DAVID L REGAN
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Regulation Number870.2100
Classification Product Code
DPW  
Date Received04/07/2003
Decision Date 04/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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