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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 K900427
Device Name IV TRIFURCATED EXTENSION SET
Applicant
Marquette Medical, Inc.
2134 Espey Ct. #7
Crofton,  MD  21114
Applicant Contact MARQUETTE JR.
Correspondent
Marquette Medical, Inc.
2134 Espey Ct. #7
Crofton,  MD  21114
Correspondent Contact MARQUETTE JR.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/30/1990
Decision Date 02/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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