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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K112887
Device Name UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
Original Applicant
UPSTREAM PERIPHERAL TECHNOLOGIES
1835 market street
29th floor
philadelphia,  PA  19103
Original Contact janice m hogan
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/30/2011
Decision Date 03/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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