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510(k) K200821

anti-bacterial bandage by Planet (Suzhou) Medical Products Co., Ltd. — Product Code FRO

K200821 is an FDA 510(k) premarket notification submitted by Planet (Suzhou) Medical Products Co., Ltd. for the device "anti-bacterial bandage". The FDA issued a decision of Substantially Equivalent on Oct 19, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 19, 2020
Date Received
Mar 30, 2020
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