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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 K882879
Device Name PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)
Original Applicant
PIONEERING TECHNOLOGIES, INC.
143 union blvd., suite 900
lakewood,  CO  80228
Original Contact wright,phd
Regulation Number870.4450
Classification Product Code
DXC  
Date Received07/11/1988
Decision Date 09/12/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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