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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 K982797
Device Name BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
Original Applicant
LUTHER MEDICAL PRODUCTS, INC.
14332 chambers rd.
tustin,  CA  92780 -6912
Original Contact kathleen roberts
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/10/1998
Decision Date 11/30/1998
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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