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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 K052658
Device Name SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET
Original Applicant
RENASCENCE MEDICAL, INC.
2536 w. industrial dr.,
suite 7
bloomington,  IN  47404
Original Contact daniel dyar
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/27/2005
Decision Date 10/12/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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