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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K021471
Device Name MARQUETTE HUBER TRAP SAFETY INFUSION SET
Applicant
Marquette Medical, Inc.
P.O. Box 4341
Crofton,  MD  20850
Applicant Contact E.J. Smith
Correspondent
Marquette Medical, Inc.
P.O. Box 4341
Crofton,  MD  20850
Correspondent Contact E.J. Smith
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJT  
Date Received05/08/2002
Decision Date 09/08/2003
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
Predetermined Change
Control Plan Authorized		 No
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