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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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls