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510(k) K082027

FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 by Genesis Bps, LLC — Product Code FPA

K082027 is an FDA 510(k) premarket notification submitted by Genesis Bps, LLC for the device "FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160". The FDA issued a decision of Substantially Equivalent on February 13, 2009. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2009
Date Received
July 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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FDA data resources