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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 K983039
Device Name EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF
Original Applicant
SCHNEIDER/NAMIC
pruyn's island
glens falls,  NY  12801
Original Contact karin l smith
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/31/1998
Decision Date 05/07/1999
Decision substantially equivalent - kit (SK)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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