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510(k) K153138

Cerdak Basic by Bu Polysciences Equipment & Trading, LLC — Product Code FRO

K153138 is an FDA 510(k) premarket notification submitted by Bu Polysciences Equipment & Trading, LLC for the device "Cerdak Basic". The FDA issued a decision of Substantially Equivalent on Jun 23, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 23, 2017
Date Received
Oct 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources