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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
Applicant
SCHNEIDER/NAMIC
PRUYN'S ISLAND
GLENS FALLS,  NY  12801
Applicant Contact KARIN L SMITH
Correspondent
SCHNEIDER/NAMIC
PRUYN'S ISLAND
GLENS FALLS,  NY  12801
Correspondent Contact KARIN L SMITH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/31/1998
Decision Date 05/07/1999
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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