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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K043446
Device Name EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
Applicant
EMMEBI SRL
6064 PARVIEW SE
GRAND RAPID,  MI  49546
Applicant Contact MARJORIE BUSH
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/14/2004
Decision Date 02/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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