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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 K901088
Device Name LOW VOLUME BIFURCATED IV EXTENSION SET
Original Applicant
MARQUETTE MEDICAL, INC.
2134 espey ct. #7
crofton,  MD  21114
Original Contact marquette jr
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/07/1990
Decision Date 10/04/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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