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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 K001139
Device Name PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
Original Applicant
3333 diamond canyon rd.
diamond bar,  CA  91765
Original Contact mary adams
Regulation Number870.1340
Classification Product Code
Date Received04/10/2000
Decision Date 05/10/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls