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510(k) K150484

Penguin In-Line Warmer by Creche Innovations — Product Code LGZ

K150484 is an FDA 510(k) premarket notification submitted by Creche Innovations for the device "Penguin In-Line Warmer". The FDA issued a decision of Substantially Equivalent on July 9, 2015. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2015
Date Received
February 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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FDA data resources