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510(k) K180533

Procellera Composite Antibacterial Wound Dressing by Vomaris Wound Care, Inc. — Product Code FRO

K180533 is an FDA 510(k) premarket notification submitted by Vomaris Wound Care, Inc. for the device "Procellera Composite Antibacterial Wound Dressing". The FDA issued a decision of Substantially Equivalent on Dec 10, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 10, 2018
Date Received
Feb 28, 2018
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