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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 K924562
Device Name CATHETER INTRODUCER
Original Applicant
LUTHER MEDICAL PRODUCTS, INC.
14332 chambers rd.
tustin,  CA  92780 6912
Original Contact barbara c luther
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/09/1992
Decision Date 02/25/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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