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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K120964
Model 106
Device Name UPSTREAM GR CATHETER
Original Applicant
UPSTREAM PERIPHERAL TECHNOLOGIES
1835 market street
29th floor
philadelphia,  PA  19103
Original Contact janice hogan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/30/2012
Decision Date 05/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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