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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 K041345
Device Name PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
Applicant
MEDIX, INC.
6250 SHIER RINGS ROAD
DUBLIN,  OH  43016
Applicant Contact BARBARA LAW
Correspondent
MEDIX, INC.
6250 SHIER RINGS ROAD
DUBLIN,  OH  43016
Correspondent Contact BARBARA LAW
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/20/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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