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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K090286
Device Name PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
Applicant
Advanced Vascular Dynamics
1910 NW 23rd Place
Portland,  OR  97210
Applicant Contact HERBERT J SEMLER
Correspondent
Advanced Vascular Dynamics
1910 NW 23rd Place
Portland,  OR  97210
Correspondent Contact HERBERT J SEMLER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/05/2009
Decision Date 03/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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