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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 K830891
Device Name SPECIALTY SET MODEL IV7A01
Original Applicant
VALLEYLAB, INC.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/21/1983
Decision Date 04/14/1983
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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